Label: NEO CLASSIC HOMME SPORTS 31700111- ensulizole, octinoxate and zinc oxide cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-123-02 - 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 November 20, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Warnings
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Directions
Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: Ask a doctor
Apply an adequate amount on the face after cleansing and toning.
Reapply at least every 2 hours.
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.
Use a water-resistant sunscreen if swimming or sweatingApply an adequate amount on the face after cleansing and toning
- OTHER SAFETY INFORMATION
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Inactive Ingredients
WATER•CYCLOPENTASILOXANE•PEG-10 DIMETHICONE•
DIMETHICONE/METHICONE COPOLYMER•BUTYLENE GLYCOL•
TITANIUM DIOXIDE•HEXYL LAURATE•METHICONE•ALUMINA•
DIMETHICONE CROSSPOLYMER•TRIETHANOLAMINE•SILICA•
DIPROPYLENE GLYCOL•CETYL ETHYLHEXANOATE•
DISTEARDIMONIUM HECTORITE•SORBITAN SESQUIOLEATE•
ACRYLATES/DIMETHICONE COPOLYMER•ZINC STEARATE•
METHYLPARABEN•PROPYLPARABEN•DISTEARYLDIMONIUM
CHLORIDE•THYLPARABEN•DISODIUM EDTA•ONSEN-SUI•
HELIANTHUS ANNUUS (SUNFLOWER)
SEED EXTRACT•MORUS ALBA BARK
EXTRACT•FRAGRANCE - QUESTIONS
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NEO CLASSIC HOMME SPORTS 31700111
ensulizole, octinoxate and zinc oxide cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 1.7 g in 45 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.3 g in 45 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.1 g in 45 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-123-02 1 in 1 CARTON 11/20/2014 1 45 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 11/20/2014 Labeler - THEFACESHOP CO., LTD. (688329416) Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193) Establishment Name Address ID/FEI Business Operations THEFACESHOP Co., Ltd. 688329416 label(51523-123)
