Label: FACE TONE CONTROLLER SPF30- octinoxate, titanium dioxide and zinc oxide cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-365-17 - Packager: THEFACESHOP CO., LTD.
- Category: HUMAN OTC DRUG LABEL
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 18, 2015
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- 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.Apply at the final stage of your skincare routine. Pat skin lightly to boost absorption.
- Other Information
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Inactive Ingredients
Chamomilla Recutita (Matricaria) Flower Water, Cyclopentasiloxane, Phenyl Trimethicone, Butylene Glycol, Caprylyl Methicone, PEG-10 Dimethicone, Glycerin, Niacinamide, Dicaprylyl Carbonate, Pentylene Glycol, Alcohol Denat., Dimethicone, Methylpropanediol, Butylene Glycol Dicaprylate/Dicaprate, Cetyl PEG/PPG-10/1 Dimethicone, Isododecane, Trimethylsiloxysilicate, Disteardimonium Hectorite, Magnesium Sulfate, Phenoxyethanol, Tribehenin, Methyl Methacrylate Crosspolymer, Saccharomyces Ferment, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Aluminum Hydroxide, Stearic Acid, Glyceryl Tribehenate/Isostearate/Eicosandioate, Dimethicone Crosspolymer, Water, Triethoxycaprylylsilane, Ethylhexylglycerin, Adenosine, Disodium EDTA, PEG-8 Dimethicone, Volcanic Ash, Chenopodium Quinoa Seed Extract, Rubus Chamaemorus Seed Extract, Fragrance, Ultramarines (CI 77007)
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PRINCIPAL DISPLAY PANEL
FACE TONE
SUNSCREEN CONTROLLER
02 FOR SALLOW AND DULL SKIN
SPF30 PA++
Skin tone controller makes dull, flaky
skin to appear brighter and revitalized.
•Create a flawless skin tone and appearance.
•Helps makeup go on more evenly and
improves its staying power.
•Contains over 37% of revitalizing serum
with Perfect Seed*
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INGREDIENTS AND APPEARANCE
FACE TONE CONTROLLER SPF30
octinoxate, titanium dioxide and zinc oxide cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-365 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.75 g in 35 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.23 g in 35 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.72 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:51523-365-17 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(51523-365)