Label: FACE IT POWER PERFECTION 32800408- octinoxate and titanium dioxide cream cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 51523-408-09 - 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.
After basic skincare, dispense an adequate amount
and apply evenly to the skin. Then, pat lightly with
the palms for full absorption.
- Other information
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Inactive Ingredients
WATER•CYCLOPENTASILOXANE•PHENYL TRIMETHICONE•
CYCLOHEXASILOXANE•BUTYLENE GLYCOL•ISODODECANE•CETYL
PEG/PPG-10/1 DIMETHICONE•NIACINAMIDE•METHYLPROPANEDIOL•
BUTYLENE GLYCOL•DICAPRYLATE/DICAPRATE•POLYGLYCERYL-4
ISOSTEARATE•SODIUM CHLORIDE•HYDROGENATED
POLYISOBUTENE•DISTEARDIMONIUM HECTORITE•METHYL
METHACRYLATE CROSSPOLYMER•SORBITAN ISOSTEARATE•
OZOKERITE•DIMETHICONE•HEXYL LAURATE•DIMETHICONE/VINYL
DIMETHICONE CROSSPOLYMER•HYDROGENATED POLY
(C6-14 OLEFIN)•CAPRYLIC/CAPRIC GLYCERIDES•
ETHYLHEXYLGLYCERIN•ALUMINUM HYDROXIDE•BEESWAX•
STEARIC ACID•TRIETHOXYCAPRYLYLSILANE•FRAGRANCE(PARFUM)•
PROPYLENE CARBONATE•DISODIUM EDTA•PRUNUS AMYGDALUS
DULCIS (SWEET ALMOND) OIL•RASPBERRY SEED OIL/TOCOPHERYL
SUCCINATE AMINOPROPANEDIOL ESTERS•ADENOSINE•PORTULACA
OLERACEA EXTRACT•XANTHAN GUM•SODIUM HYALURONATE•
PLUKENETIA VOLUBILIS SEED OIL•ALUMINA•RETINOL•LINOLEIC
ACID•CERAMIDE 3•TOCOPHEROL•ASCORBIC ACID•HYDROLYZED
EXTENSIN•GLYCERIN•SCHINUS TEREBINTHIFOLIUS SEED EXTRACT•
PHENOXYETHANOL•GYNOSTEMMA PENTAPHYLLUM LEAF/STEM
EXTRACT•CALCIUM ALUMINUM BOROSILICATE•BETA-GLUCAN•
METHYLPARABEN•BUTYLPARABEN•ETHYLPARABEN•
ISOBUTYLPARABEN•PROPYLPARABEN•IRON
OXIDES (CI 77491, CI 77492, CI 77499)•ZINC OXIDE (CI 77947)
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACE IT POWER PERFECTION 32800408
octinoxate and titanium dioxide cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-408 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1 g in 20 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.94 g in 20 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-408-09 1 in 1 CARTON 11/20/2014 1 20 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(51523-408)
