Label: FACE IT HD PERFECT BB 32800473- octinoxate, zinc oxide and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-473-13 - 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
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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 after skincare products. Blend evenly with fingertips
and gently pat into skin.
- Other information
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Inactive Ingredients
WATER•CYCLOPENTASILOXANE•CYCLOHEXASILOXANE•
DIPROPYLENE GLYCOL•LAURYL PEG-9
POLYDIMETHYLSILOXYETHYL DIMETHICONE•BETAINE•
GLYCERIN•HYDROGENATED POLYISOBUTENE•
DISTEARDIMONIUM HECTORITE•DIMETHICONE•MAGNESIUM
SULFATE•TALC•PHENOXYETHANOL•METHYLPARABEN•
DIMETHICONE/PEG-10/15 CROSSPOLYMER•POLYGLYCERYL-4
ISOSTEARATE•CETYL PEG/PPG-10/1 DIMETHICONE•
BIS-VINYL DIMETHICONE/DIMETHICONE COPOLYMER•
STEARIC ACID•DISTEARYLDIMONIUM CHLORIDE•
TRIETHOXYCAPRYLYLSILANE•ALUMINUM HYDROXIDE•
PROPYLPARABEN•ETHYLPARABEN•TOCOPHERYL ACETATE•
BUTYLPHENY METHYLPROPIONAL•HYDROXYISOHEXYL
3-CYCLOHEXENE CARBOXALDEHYDE•HEXYL LAURATE•
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER•
LINALOOL•PORTULACA OLERACEA EXTRACT•CITRONELLOL•
LIMONENE•BUTYLENE GLYCOL•MEDICAGO SATIVA (ALFALFA)
LEAF EXTRACT•RAPHANUS SATIVUS (RADISH) LEAF
EXTRACT•TRIFOLIUM REPENS EXTRACT•BRASSICA
OLERACEA ITALICA (BROCCOLI) SPROUT EXTRACT•SILICA•
NELUMBO NUCIFERA LEAF EXTRACT•LYCIUM CHINENSE
ROOT EXTRACT•KOCHIA SCOPARIA FRUIT
EXTRACT•FRAGRANCE•IRON OXIDES
(CI 77491, CI 77492, CI 77499)
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACE IT HD PERFECT BB 32800473
octinoxate, zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-473 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.8 g in 40 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.2 g in 40 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.4 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:51523-473-13 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(51523-473)
