ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION  - titanium dioxide and zinc oxide powder 
J. A. Cosmetics U.S. INC

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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Active Ingredient:

Titanium Dioxide: 23.3%

Zinc Oxide: 18.7%

Purpose:

Sunscreen

Uses:

Help prevent sunburns

Warning:

For external use only

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 to only help prevent sunburn, not skin cancer and skin aging.

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)

Protect this product in its container away from excessive heat and direct sun

Inactive Ingredient:

Mica, Silica, Talc, Bismuth Oxychloride, Boron Nitride, Aluminum Hydroxide, Vitis Vinifera (Grape) Seed Extract, Aloe Barbadensis Leaf Extract, Retinyl Palmitate (VA), Tocopheryl Acetate (VE), Magnesium Ascorbyl Phosphate (VC), Sodium Dehydroacetate

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:76354-016
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE23.3 g  in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE18.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BISMUTH OXYCHLORIDE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
MICA 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
SILICON DIOXIDE 
TALC 
ALUMINUM HYDROXIDE 
SODIUM DEHYDROACETATE 
ALOE VERA LEAF 
GRAPE SEED OIL 
VITAMIN A PALMITATE 
MAGNESIUM ASCORBYL PHOSPHATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:76354-016-0110 g in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/22/2011

Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIOperations
Shanghai Justking Enterprise Co., Ltd 421267459manufacture

Revised: 10/2011 J. A. Cosmetics U.S. INC