Label: ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION- titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 52664-010-01 - Packager: Hangzhou Facecare Cosmetics Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
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 17, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive Ingredient:
Mica, Silica, Talc, Bismuth Oxychloride, Boron Nitride, Aluminum Hydroxide, Sodium Dehydroacetate, Vitis Vinifera (Grape) Seed Extract, Aloe Barbadensis Leaf Extract, Retinyl Palmitate (VA), Tocopheryl Acetate (VE)
May contain:
Iron Oxides (CI 77491, CI 77492, CI 77499), Manganese Violet (CI 77742)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION
titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52664-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 21.25 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17 g in 100 g Inactive Ingredients Ingredient Name Strength BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) ALOE VERA LEAF (UNII: ZY81Z83H0X) GRAPE SEED OIL (UNII: 930MLC8XGG) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52664-010-01 10 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/01/2010 Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856) Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856) Establishment Name Address ID/FEI Business Operations Hangzhou Facecare Cosmetics Co., Ltd. 545341856 manufacture