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FDA Registration for Cosmetics
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FDA Registration – Cosmetics 化妆品注册

The U.S. Food and Drug Administration [ FDA ] offers voluntary registration for U.S. and non-U.S. manufacturers, packers, and distributors of cosmetics to be sold in the United States. In addition, companies may file a voluntary cosmetic product ingredient statement ( CPIS ) with FDA, although registration and CPIS filings may not be used for marketing purposes. 美国食品和药物管理局要求境内外所有在美生产, 包装或销售的企业, 都要进行自主申报注册. 此外, 企业也可以将产品的成分配方信息在FDA进行备案.

We offer below service: 我们为您提供如下服务:

• Many common cosmetics are regulated by FDA as Drug. Example include sunscreen lotions, antiperspirants, and toothpastes. We assists in determining how FDA may likely regulate your product and provides services to be full compliance. 很多常用的化妆品都有可能被FDA归类为药物. 例如: 防晒霜, 止汗液或是牙膏. 我们能帮助企业合理协调注册信息, 使其正确归类.

•Update your registration with FDA as needed. 帮助客户按照FDA要求及时更新注册信息.

• Facilitate interactions with FDA, including scheduling of FDA inspection. 帮助客户与FDA保持信息互通, 包括通知安排验货服务.

• California safe cosmetics program and FDA voluntary cosmetic registration program. 加洲化妆品安全计划和FDA化妆品自主申报注册

•Labeling review 化妆品标签,标识审核

Sample Report报告样本：

已经被FDA允许的化妆品添加剂清单

Spices and other natural seasonings and flavorings that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

Common name	Botanical name of plant source
Alfalfa herb and seed	Medicago sativa L.
Allspice	Pimenta officinalis Lindl.
Ambrette seed	Hibiscus abelmoschus L.
Angelica	Angelica archangelica L. or other spp. of Angelica.
Angelica root	Do.
Angelica seed	Do.
Angostura (cusparia bark)	Galipea officinalis Hancock.
Anise	Pimpinella anisum L.
Anise, star	Illicium verum Hook. f.
Balm (lemon balm)	Melissa officinalis L.
Basil, bush	Ocimum minimum L.
Basil, sweet	Ocimum basilicum L.
Bay	Laurus nobilis L.
Calendula	Calendula officinalis L.
Camomile (chamomile), English or Roman	Anthemis nobilis L.
Camomile (chamomile), German or Hungarian	Matricaria chamomilla L.
Capers	Capparis spinosa L.
Capsicum	Capsicum frutescens L. or Capsicum annuum L.
Caraway	Carum carvi L.
Caraway, black (black cumin)	Nigella sativa L.
Cardamom (cardamon)	Elettaria cardamomum Maton.
Cassia, Chinese	Cinnamomum cassia Blume.
Cassia, Padang or Batavia	Cinnamomum burmanni Blume.
Cassia, Saigon	Cinnamomum loureirii Nees.
Cayenne pepper	Capsicum frutescens L. or Capsicum annuum L.
Celery seed	Apium graveolens L.
Chervil	Anthriscus cerefolium (L.) Hoffm.
Chives	Allium schoenoprasum L.
Cinnamon, Ceylon	Cinnamomum zeylanicum Nees.
Cinnamon, Chinese	Cinnamomum cassia Blume.
Cinnamon, Saigon	Cinnamomum loureirii Nees.
Clary (clary sage)	Salvia sclarea L.
Clover	Trifolium spp.
Coriander	Coriandrum sativum L.
Cumin (cummin)	Cuminum cyminum L.
Cumin, black (black caraway)	Nigella sativa L.
Elder flowers	Sambucus canadensis L.
Fennel, common	Foeniculum vulgare Mill.
Fennel, sweet (finocchio, Florence fennel)	Foeniculum vulgare Mill. var. duice (DC.) Alex.
Fenugreek	Trigonella foenum-graecum L.
Galanga (galangal)	Alpinia officinarum Hance.
Geranium	Pelargonium spp.
Ginger	Zingiber officinale Rosc.
Grains of paradise	Amomum melegueta Rosc.
Horehound (hoarhound)	Marrubium vulgare L.
Horseradish	Armoracia lapathifolia Gilib.
Hyssop	Hyssopus officinalis L.
Lavender	Lavandula officinalis Chaix.
Linden flowers	Tilia spp.
Mace	Myristica fragrans Houtt.
Marigold, pot	Calendula officinalis L.
Marjoram, pot	Majorana onites (L.) Benth.
Marjoram, sweet	Majorana hortensis Moench.
Mustard, black or brown	Brassica nigra (L.) Koch.
Mustard, brown	Brassica juncea (L.) Coss.
Mustard, white or yellow	Brassica hirta Moench.
Nutmeg	Myristica fragrans Houtt.
Oregano (oreganum, Mexican oregano, Mexican sage, origan)	Lippia spp.
Paprika	Capsicum annuum L.
Parsley	Petroselinum crispum (Mill.) Mansf.
Pepper, black	Piper nigrum L.
Pepper, cayenne	Capsicum frutescens L. or Capsicum annuum L.
Pepper, red	Do.
Pepper, white	Piper nigrum L.
Peppermint	Mentha piperita L.
Poppy seed	Papayer somniferum L.
Pot marigold	Calendula officinalis L.
Pot marjoram	Majorana onites (L.) Benth.
Rosemary	Rosmarinus officinalis L.
Saffron	Crocus sativus L.
Sage	Salvia officinalis L.
Sage, Greek	Salvia triloba L.
Savory, summer	Satureia hortensis L. (Satureja).
Savory, winter	Satureia montana L. (Satureja).
Sesame	Sesamum indicum L.
Spearmint	Mentha spicata L.
Star anise	Illicium verum Hook. f.
Tarragon	Artemisia dracunculus L.
Thyme	Thymus vulgaris L.
Thyme, wild or creeping	Thymus serpyllum L.
Turmeric	Curcuma longa L.
Vanilla	Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore.
Zedoary	Curcuma zedoaria Rosc.

[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 3705, Jan. 27, 1978; 44 FR 3963, Jan. 19, 1979; 50 FR 21044, May 22, 1985; 61 FR 14246, Apr. 1, 1996]

§182.20 Essential oils, oleoresins (solvent-free), and natural extractives (including distillates).

Essential oils, oleoresins (solvent-free), and natural extractives (including distillates) that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

Common name	Botanical name of plant source
Alfalfa	Medicago sativa L.
Allspice	Pimenta officinalis Lindl.
Almond, bitter (free from prussic acid)	Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch.
Ambrette (seed)	Hibiscus moschatus Moench.
Angelica root	Angelica archangelica L.
Angelica seed	Do.
Angelica stem	Do.
Angostura (cusparia bark)	Galipea officinalis Hancock.
Anise	Pimpinella anisum L.
Asafetida	Ferula assa-foetida L. and related spp. of Ferula.
Balm (lemon balm)	Melissa officinalis L.
Balsam of Peru	Myroxylon pereirae Klotzsch.
Basil	Ocimum basilicum L.
Bay leaves	Laurus nobilis L.
Bay (myrcia oil)	Pimenta racemosa (Mill.) J. W. Moore.
Bergamot (bergamot orange)	Citrus aurantium L. subsp. bergamia Wright et Arn.
Bitter almond (free from prussic acid)	Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch.
Bois de rose	Aniba rosaeodora Ducke.
Cacao	Theobroma cacao L.
Camomile (chamomile) flowers, Hungarian	Matricaria chamomilla L.
Camomile (chamomile) flowers, Roman or English	Anthemis nobilis L.
Cananga	Cananga odorata Hook. f. and Thoms.
Capsicum	Capsicum frutescens L. and Capsicum annuum L.
Caraway	Carum carvi L.
Cardamom seed (cardamon)	Elettaria cardamomum Maton.
Carob bean	Ceratonia siliqua L.
Carrot	Daucus carota L.
Cascarilla bark	Croton eluteria Benn.
Cassia bark, Chinese	Cinnamomum cassia Blume.
Cassia bark, Padang or Batavia	Cinnamomum burmanni Blume.
Cassia bark, Saigon	Cinnamomum loureirii Nees.
Celery seed	Apium graveolens L.
Cherry, wild, bark	Prunus serotina Ehrh.
Chervil	Anthriscus cerefolium (L.) Hoffm.
Chicory	Cichorium intybus L.
Cinnamon bark, Ceylon	Cinnamomum zeylanicum Nees.
Cinnamon bark, Chinese	Cinnamomum cassia Blume.
Cinnamon bark, Saigon	Cinnamomum loureirii Nees.
Cinnamon leaf, Ceylon	Cinnamomum zeylanicum Nees.
Cinnamon leaf, Chinese	Cinnamomum cassia Blume.
Cinnamon leaf, Saigon	Cinnamomum loureirii Nees.
Citronella	Cymbopogon nardus Rendle.
Citrus peels	Citrus spp.
Clary (clary sage)	Salvia sclarea L.
Clover	Trifolium spp.
Coca (decocainized)	Erythroxylum coca Lam. and other spp. of Erythroxylum.
Coffee	Coffea spp.
Cola nut	Cola acuminata Schott and Endl., and other spp. of Cola.
Coriander	Coriandrum sativum L.
Cumin (cummin)	Cuminum cyminum L.
Curacao orange peel (orange, bitter peel)	Citrus aurantium L.
Cusparia bark	Galipea officinalis Hancock.
Dandelion	Taraxacum officinale Weber and T. laevigatum DC.
Dandelion root	Do.
Dog grass (quackgrass, triticum)	Agropyron repens (L.) Beauv.
Elder flowers	Sambucus canadensis L. and S. nigra I.
Estragole (esdragol, esdragon, tarragon)	Artemisia dracunculus L.
Estragon (tarragon)	Do.
Fennel, sweet	Foeniculum vulgare Mill.
Fenugreek	Trigonella foenum-graecum L.
Galanga (galangal)	Alpinia officinarum Hance.
Geranium	Pelargonium spp.
Geranium, East Indian	Cymbopogon martini Stapf.
Geranium, rose	Pelargonium graveolens L'Her.
Ginger	Zingiber officinale Rosc.
Grapefruit	Citrus paradisi Macf.
Guava	Psidium spp.
Hickory bark	Carya spp.
Horehound (hoarhound)	Marrubium vulgare L.
Hops	Humulus lupulus L.
Horsemint	Monarda punctata L.
Hyssop	Hyssopus officinalis L.
Immortelle	Helichrysum augustifolium DC.
Jasmine	Jasminum officinale L. and other spp. of Jasminum.
Juniper (berries)	Juniperus communis L.
Kola nut	Cola acuminata Schott and Endl., and other spp. of Cola.
Laurel berries	Laurus nobilis L.
Laurel leaves	Laurus spp.
Lavender	Lavandula officinalis Chaix.
Lavender, spike	Lavandula latifolia Vill.
Lavandin	Hybrids between Lavandula officinalis Chaix and Lavandula latifolin Vill.
Lemon	Citrus limon (L.) Burm. f.
Lemon balm (see balm)
Lemon grass	Cymbopogon citratus DC. and Cymbopogon lexuosus Stapf.
Lemon peel	Citrus limon (L.) Burm. f.
Lime	Citrus aurantifolia Swingle.
Linden flowers	Tilia spp.
Locust bean	Ceratonia siliqua L,
Lupulin	Humulus lupulus L.
Mace	Myristica fragrans Houtt.
Mandarin	Citrus reticulata Blanco.
Marjoram, sweet	Majorana hortensis Moench.
Maté	Ilex paraguariensis St. Hil.
Melissa (see balm)
Menthol	Mentha spp.
Menthyl acetate	Do.
Molasses (extract)	Saccarum officinarum L.
Mustard	Brassica spp.
Naringin	Citrus paradisi Macf.
Neroli, bigarade	Citrus aurantium L.
Nutmeg	Myristica fragrans Houtt.
Onion	Allium cepa L.
Orange, bitter, flowers	Citrus aurantium L.
Orange, bitter, peel	Do.
Orange leaf	Citrus sinensis (L.) Osbeck.
Orange, sweet	Do.
Orange, sweet, flowers	Do.
Orange, sweet, peel	Do.
Origanum	Origanum spp.
Palmarosa	Cymbopogon martini Stapf.
Paprika	Capsicum annuum L.
Parsley	Petroselinum crispum (Mill.) Mansf.
Pepper, black	Piper nigrum L.
Pepper, white	Do.
Peppermint	Mentha piperita L.
Peruvian balsam	Myroxylon pereirae Klotzsch.
Petitgrain	Citrus aurantium L.
Petitgrain lemon	Citrus limon (L.) Burm. f.
Petitgrain mandarin or tangerine	Citrus reticulata Blanco.
Pimenta	Pimenta officinalis Lindl.
Pimenta leaf	Pimenta officinalis Lindl.
Pipsissewa leaves	Chimaphila umbellata Nutt.
Pomegranate	Punica granatum L.
Prickly ash bark	Xanthoxylum (or Zanthoxylum) Americanum Mill. or Xanthoxylum clava-herculis L.
Rose absolute	Rosa alba L., Rosa centifolia L., Rosa damascena Mill., Rosa gallica L., and vars. of these spp.
Rose (otto of roses, attar of roses)	Do.
Rose buds	Do.
Rose flowers	Do.
Rose fruit (hips)	Do.
Rose geranium	Pelargonium graveolens L'Her.
Rose leaves	Rosa spp.
Rosemary	Rosmarinus officinalis L.
Saffron	Crocus sativus L.
Sage	Salvia officinalis L.
Sage, Greek	Salvia triloba L.
Sage, Spanish	Salvia lavandulaefolia Vahl.
St. John's bread	Ceratonia siliqua L.
Savory, summer	Satureia hortensis L.
Savory, winter	Satureia montana L.
Schinus molle	Schinus molle L.
Sloe berries (blackthorn berries)	Prunus spinosa L.
Spearmint	Mentha spicata L.
Spike lavender	Lavandula latifolia Vill.
Tamarind	Tamarindus indica L.
Tangerine	Citrus reticulata Blanco.
Tarragon	Artemisia dracunculus L.
Tea	Thea sinensis L.
Thyme	Thymus vulgaris L. and Thymus zygis var. gracilis Boiss.
Thyme, white	Do.
Thyme, wild or creeping	Thymus serpyllum L.
Triticum (see dog grass)
Tuberose	Polianthes tuberosa L.
Turmeric	Curcuma longa L.
Vanilla	Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore.
Violet flowers	Viola odorata L.
Violet leaves	Do.
Violet leaves absolute	Do.
Wild cherry bark	Prunus serotina Ehrh.
Ylang-ylang	Cananga odorata Hook. f. and Thoms.
Zedoary bark	Curcuma zedoaria Rosc.

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FDA Registration for Cosmetics

§182.20 Essential oils, oleoresins (solvent-free), and natural extractives (including distillates).

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