BEAUTY FOX ATOCLINIC- dimethicone cream 
Beauty Fox Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

DIMETHICONE 1.00%

Skin Protectant

Helps to prevent dehydration of skin

Apply liberally as needed onto skin

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Centella Asiatica Leaf Water, Purified Water, Water, Glycerin, Centella Asiatica Extract, Butylene Glycol , Butylene Glycol Dicaprylate/Dicaprate, Sunflower Seed Oil, Caprylic/Capric Triglyceride, Dipropylene Glycol, Squalane, Sorbitan Stearate, Beeswax, Cetyl Alcohol, Stearyl Alcohol, Cyclopentasiloxane, Betaine, Macadamia Seed Oil, Cyclohexasiloxane, Shea Butter, Cetearyl Olivate, Polysorbate 60, Caprylyl Glycol, Sorbitan Olivate, Polysorbate 80, Isohexadecane, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Carbomer, Arginine, Allantoin, Caprylhydroxamic Acid, Tocopheryl Acetate, Tremella Fuciformis (Mushroom) Extract, Olive Oil, Asiaticoside, Avocado Oil, Punica Granatum Seed Oil, Hippophae Rhamnoides Fruit Extract, Β-Glucan, Adansonia Digitata Seed Oil, Portulaca Oleracea Extract, Dipotassium Glycyrrhizate, Witch Hazel Water, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Orange Oil, Citrus Paradisi (Grapefruit) Peel Oil, Avena Sativa (Oat) Kernel Extract, Rosemary Leaf Oil, Citrus Lemon Peel Oil, Triticum Vulgare (Wheat) Sprout Extract, Brassica Napus Sprout Extract, Brassica Oleracea Italica (Broccoli) Sprout Extract, Phaseolus Radiatus Sprout Extract, Lavender Oil, Ceramide 3, Madecassoside, Medicago Sativa (Alfalfa) Sprout Extract, Eucalyptus Globulus Leaf Oil, Lepidium Sativum Sprout Extract, Glycine Soja (Soybean) Sprout Extract, Carthamus Tinctorius (Safflower) Sprout Extract, Cedrus Atlantica Bark Oil, Pelargonium Graveolens Flower Oil, Trifolium Repens Sprout Extract, Eugenia Caryophylus (Clove) Bud Extract, Angelica Gigas Sprout Extract, Poltgonum Fagopyrum (Buckwheat) Sporout Extract, Thymus Vulgaris (Thyme) Extract, Buddleja Davidii Extract, 1,2-Hexanediol, Michelia Alba Flower Oil, Styrax Benzoin Resin Extract, Chamomilla Recutita (Matricaria) Flower Oil, Rose Flower Oil, Orange Flower Oil

image description

BEAUTY FOX ATOCLINIC 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70129-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.6 g  in 160 g
Inactive Ingredients
Ingredient NameStrength
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
SQUALANE (UNII: GW89575KF9)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BETAINE (UNII: 3SCV180C9W)  
MACADAMIA OIL (UNII: 515610SU8C)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SHEA BUTTER (UNII: K49155WL9Y)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
ARGININE (UNII: 94ZLA3W45F)  
ALLANTOIN (UNII: 344S277G0Z)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CULTIVATED MUSHROOM (UNII: 54C8E6W6JY)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ASIATICOSIDE (UNII: PKO39VY215)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
CURDLAN (UNII: 6930DL209R)  
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
PURSLANE (UNII: M6S840WXG5)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE OIL (UNII: AKN3KSD11B)  
GRAPEFRUIT OIL (UNII: YR377U58W9)  
OAT (UNII: Z6J799EAJK)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
LEMON OIL (UNII: I9GRO824LL)  
WHEAT SPROUT (UNII: 3K32950CI0)  
BROCCOLI SPROUT (UNII: 128UH9LOAE)  
BEAN SPROUT (UNII: 9VZY890UEQ)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
CERAMIDE 3 (UNII: 4370DF050B)  
MADECASSOSIDE (UNII: CQ2F5O6YIY)  
ALFALFA TOP (UNII: SQI2NBY9KR)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
SOYBEAN (UNII: L7HT8F1ZOD)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
CLOVE (UNII: K48IKT5321)  
ANGELICA GIGAS ROOT (UNII: 32766B2FHX)  
BUCKWHEAT (UNII: N0Y68724R3)  
THYME (UNII: CW657OBU4N)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
MAGNOLIA X ALBA FLOWER OIL (UNII: 8QDN200R1S)  
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW)  
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70129-001-021 in 1 CARTON09/30/2015
1NDC:70129-001-01160 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/30/2015
Labeler - Beauty Fox Co., Ltd. (688993629)
Registrant - Beauty Fox Co., Ltd. (688993629)
Establishment
NameAddressID/FEIBusiness Operations
Beauty Fox Co., Ltd.688993629manufacture(70129-001)

Revised: 9/2015
Document Id: e0ddec7d-b2c6-44ee-95af-0e76fb73cc83
Set id: 3d590c6d-46ad-4df9-8927-ff75e9e1104d
Version: 1
Effective Time: 20150930
 
Beauty Fox Co., Ltd.