Label: AIR COTTON MAKE UP BASE 01 MINT SPF 30- titanium dioxide and zinc oxide cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-362-15 - 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 October 1, 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:
Water, Cyclopentasiloxane, Cyclohexasiloxane, Dipropylene Glycol, Butylene Glycol, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Dicaprylate/Dicaprate, PEG-10 Methyl Ether Dimethicone, Sodium Chloride, Dimethicone, Aluminum Hydroxide, Stearic Acid, Disteardimonium Hectorite, Caprylyl Glycol, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydrogen Dimethicone, Volcanic Ash, Anthemis Nobilis Flower Water, Triethyl Citrate, Ethylhexylglycerin, 1,2-Hexanediol, Adenosine, Disodium EDTA, Triethoxycaprylylsilane, Hydrogenated Lecithin, Caprylhydroxamic Acid, Citric Acid, Sodium Benzoate, Potassium sorbate, Glycerin, Chenopodium Quinoa Seed Extract, Gossypium Herbaceum (Cotton) Extract, Fragrance, Mica (CI 77019), Chromium Oxide Greens
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INGREDIENTS AND APPEARANCE
AIR COTTON MAKE UP BASE 01 MINT SPF 30
titanium dioxide and zinc oxide cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-362 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.04 g in 40 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.16 g in 40 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-362-15 40 mL in 1 TUBE; Type 0: Not a Combination Product 10/01/2015 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(51523-362) Establishment Name Address ID/FEI Business Operations Cosmecca Korea Co.,Ltd. 688830827 manufacture(51523-362)
