Label: FACE IT AQUA TINTED 32800421- octinoxate cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 51523-421-11 - 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
- Uses
- Warnings
-
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 after skincare products. Blend evenly with
fingertips and gently pat into skin.
- Other information
-
Inactive Ingredients
WATER•TITANIUM DIOXIDE•CYCLOMENTHICONE•
BUTYLENE GLYCOL•HEXYL LAURATE•GLYCERIN•
SD ALCOHOL 40-B•BIOSACCHARIDE GUM-1•
PORTULACA OLERACEA EXTRACT•
HYDROXYETHYL ACRYLATE/SODIUM
ACRYLOYLDIMETHYL TAURATE COPOLYMER•
C9-15 FLUOROALCOHOL PHOSPHATE•SQUALANE•
PHENOXYETHANOL•TALC•METHYLPARABEN•
ALUMINUM HYDROXIDE, ETHYLPARABEN•
POLYSORBATE 60•BUTYLPFENYL
METHYLPROPIONAL•HYDROXYISOHEXYL
3-CYCLOHEXENE CARBOXALDEHYDE•LINALOOL•
BUTYLPFENYL METHYLPROPIONAL•
CITRONELLOL•LIMONENE•SEA WATER•
PONCIRUS TRIFOLIATA FRUIT EXTRACT•
TRIETHOXYCAPRYLYLSILANE•
FRAGRANCE•IRON OXIDES
(CI 77491, CI 77492, CI 77499)
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FACE IT AQUA TINTED 32800421
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-421 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2 g in 40 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-421-11 1 in 1 CARTON 11/20/2014 1 40 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(51523-421)
