Label: 15HR COVER LASTING SPF50- octinoxate, octisalate, titanium dioxide and zinc oxide cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-371-23 - 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 21, 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 Information
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Inactive Ingredients
Chamomilla Recutita (Matricaria) Flower Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Cyclohexasiloxane, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Niacinamide, Methylpropanediol, Pentylene Glycol, Hydrogenated Polyisobutene, Polyglyceryl-4 Isostearate, Disteardimonium Hectorite, Phenyl Trimethicone, Sorbitan Isostearate, Magnesium Sulfate, Phenoxyethanol, Ozokerite, Dimethicone, Hexyl Laurate, Aluminum Hydroxide, Stearic Acid, Dimethicone Crosspolymer, Saccharomyces Ferment, Triethoxycaprylylsilane, Beeswax, Ethylhexylglycerin, Disodium EDTA, Adenosine, Xanthan Gum, Hydrogenated Castor Oil Isostearate, Volcanic Ash, Chenopodium Quinoa Seed Extract, Water, Rubus Chamaemorus Seed Extract, Fragrance, Mica (CI 77019), Iron Oxides (CI 77492, CI 77499, CI 77491)
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INGREDIENTS AND APPEARANCE
15HR COVER LASTING SPF50
octinoxate, octisalate, titanium dioxide and zinc oxide cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-371 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.45 g in 35 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.58 g in 35 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.03 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:51523-371-23 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(51523-371) Establishment Name Address ID/FEI Business Operations COSMAX INC. 689019313 manufacture(51523-371)
