Label: BARE SKIN NUDE FOUNDATION V201 APRICOT BEIGE SPF30- octinoxate, octisalate cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-366-18 - Packager: THEFACESHOP CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 29, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses:
- Warnings
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Directions
Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: Ask a doctor.
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.Dispense an adequate amount and apply to skin. Pat skin lightly to boost absorption.
- OTHER SAFETY INFORMATION
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Inactive Ingredients:
CHAMOMILLA RECUTITA (MATRICARIA) FLOWER WATER, CYCLOPENTASILOXANE, TITANIUM DIOXIDE, PROPYLENE GLYCOL, ISODODECANE, ETHYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, TALC, HYDROGENATED POLY(C6-14 OLEFIN), NIACINAMIDE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIDECYL TRIMELLITATE, ZINC OXIDE, BUTYLENE GLYCOL, DIMETHICONE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, DISTEARDIMONIUM HECTORITE, PEG-10 DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, MAGNESIUM SULFATE, BETAINE, PORTULACA OLERACEA EXTRACT, 1,2-HEXANEDIOL, PHENOXYETHANOL, ALUMINUM HYDROXIDE, AMINOPROPYL DIMETHICONE, ALUMINUM STEARATE, METHICONE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYMETHYLSILSESQUIOXANE, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, ALUMINA, ADENOSINE, SILICA, TRIETHOXYCAPRYLYLSILANE, RUBUS CHAMAEMORUS SEED EXTRACT, VOLCANIC ASH, WATER, CHENOPODIUM QUINOA SEED EXTRACT, FRAGRANCE, IRON OXIDES(CI 77491, CI 77492, CI 77499)
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INGREDIENTS AND APPEARANCE
BARE SKIN NUDE FOUNDATION V201 APRICOT BEIGE SPF30
octinoxate, octisalate cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-366 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.1 g in 35 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.7 g in 35 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-366-18 1 in 1 CARTON 10/01/2015 1 35 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2015 Labeler - THEFACESHOP CO., LTD. (688329416) Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193) Establishment Name Address ID/FEI Business Operations THEFACESHOP CO., LTD. 688329416 label(51523-366) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(51523-366)