Label: FULL STAY 24HR SPF50- octinoxate, octisalate, titanium dioxide and zinc oxide cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-456-32 - 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 28, 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.Open the product and press the button in front once or twice. Dispense an adequate amount on the puff and apply all over the face. Finish with a patting motion. If contents does not dispense well after the button is pressed, shake the product gently and try again. Press the button carefully not to spurt contents.
- OTHER SAFETY INFORMATION
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Inactive Ingredients:
Water, Cyclopentasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Dicaprylyl Carbonate, Glycerin, Niacinamide, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Pentylene Glycol, Phenyl Trimethicone, Methyl Methacrylate Crosspolymer, Butylene Glycol, Disteardimonium Hectorite, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Caprylyl Methicone, Dimethicone, Tribehenin, Aluminum Hydroxide, Sorbitan Isostearate, Phenoxyethanol, Glyceryl Tribehenate/Isostearate/Eicosandioate, Stearic Acid, Dimethicone Crosspolymer, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Adenosine, Hydrogenated Castor Oil Isostearate, Disodium EDTA, Lauroyl Lysine, HDI/Trimethylol Hexyllactone Crosspolymer, Rosa Damascena Flower Water, Silica, Pancratium Maritimum Extract, Fragrance, Mica (CI 77019), Iron Oxides (CI 77491, CI 77492, CI 77499)
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INGREDIENTS AND APPEARANCE
FULL STAY 24HR SPF50
octinoxate, octisalate, titanium dioxide and zinc oxide cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-456 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.12 g in 16 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.72 g in 16 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.14 g in 16 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.78 g in 16 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-456-32 1 in 1 CARTON 10/01/2015 1 16 g in 1 CONTAINER; 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(51523-456)