ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION - titanium dioxide powder 
Hangzhou Facecare Cosmetics Co., Ltd.

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.

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Drug Fact

Active Ingredient:

Titanium Dioxide: 21.25%

Zinc Oxide: 17%

Purpose:

Sunscreen

Uses:

Help prevent sunburns

Higher SPF gives more sunburn protection

Warning:

For external use only

When Using This Product:

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask a Doctor if:

Rash or irritation develops and lasts

Keep Out of Reach of Children:

If swallowed get medical help or contact a Poison Control Center immediately

Directions:

Apply as needed for 15-20 minutes of sun exposure

Other Imformation:

Store at room temperature 15-30C (59-86F)

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)

labelabel

ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION 
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52664-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE21.25 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52664-010-0110 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2010
Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Facecare Cosmetics Co., Ltd.545341856manufacture

Revised: 11/2010
Document Id: 69da62c0-818c-4787-9649-5fdb3268504f
Set id: 40dc37ac-dcf2-4cf7-86ce-93c0cf274e02
Version: 1
Effective Time: 20101117
 
Hangzhou Facecare Cosmetics Co., Ltd.