Label: NATURAL SUN ECO AQUA SUNSCREEN GEL 40 SPF- avobenzone, ensulizole, octinoxate and octisalate gel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-176-04 - 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.Apply an adequate amount on the face and neck at the final stage of skincare.
- OTHER SAFETY INFORMATION
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Inactive Ingredients
WATER, CYCLOPENTASILOXANE, ALCOHOL DENAT., ISOAMYL P-METHOXYCINNAMATE, POLYGLYCERYL-6 STEARATE, POLYGLYCERYL-6 BEHENATE, ETHYLHEXYL METHOXYCRYLENE, TROMETHAMINE, DIPROPYLENE GLYCOL, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, SODIUM POLYACRYLATE, PROPANEDIOL, CAPRYLHYDROXAMIC ACID, PANTHENOL, CETEARYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, SODIUM HYDROXIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, XANTHAN GUM, TRISODIUM EDTA, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, SODIUM BENZOATE, MENTHYL PCA, SODIUM PCA, FRAGRANCE
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INGREDIENTS AND APPEARANCE
NATURAL SUN ECO AQUA SUNSCREEN GEL 40 SPF
avobenzone, ensulizole, octinoxate and octisalate gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-176 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.15 g in 50 mL ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 1.75 g in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.25 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-176-04 1 in 1 CARTON 10/01/2015 1 50 mL 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(51523-176)
