ELF TINTED MOISTURIZER SPF 15  - oxybenzone and octinoxate cream 
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:

Benzophenone-3: 3.5%

Octyl Methoxycinnamate: 7.5%

Purpose:

Sunscreen

Uses: Help prevent sunburn

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 or skin aging.

When Using This Product:

Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If:

Rash occurs

Keep Out of Reach Of Children

Directions:

Apply liberally as needed 15-20 minutes before sun exposure

Reapply as needed or after swimming or towel drying

Other Information:

Protect the product in this container from excessive heat and direct sun

Inactive Ingredient:

Water, Caprylic/Capric Triglyceride, Kaolin, Titanium Dioxide, Talc, Mica, Octyl Palmitate, Glyceryl Stearate, Synthetic Beeswax,  Stearic Acid, Stearyl Alcohol, DEA-Cetyl Phosphate, Propylene Glycol, Magnesium Aluminum Silicate, Phenoxyehtanol, Triethanolamine, Xanthan Gum, Fragrance, Methylparaben, Propylparaben, Ethylparaben, Disodium EDTA.

May contain:

Iron Oxides (CI 77491, CI 77492, CI 77499)

labelabel


ELF TINTED MOISTURIZER SPF 15 
oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-006
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (OXYBENZONE) OXYBENZONE3.5 g  in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES 
TITANIUM DIOXIDE 
MICA 
METHYLPARABEN 
PROPYLPARABEN 
KAOLIN 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TALC 
ETHYLHEXYL PALMITATE 
GLYCERYL MONOSTEARATE 
WHITE WAX 
STEARIC ACID 
STEARYL ALCOHOL 
DIETHANOLAMINE CETYL PHOSPHATE 
PROPYLENE GLYCOL 
MAGNESIUM ALUMINUM SILICATE 
PHENOXYETHANOL 
TROLAMINE 
XANTHAN GUM 
ETHYLPARABEN 
EDETATE DISODIUM 
WATER42.35 g  in 100 g
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:76354-006-0112 g in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/09/2011

Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIOperations
Shanghai Justking Enterprise Co., Ltd421267459manufacture

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