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ELF Tinted Moisturizer SPF 20 by J. A. Cosmetics U.S. INC

Dosage form: cream
Ingredients: OXYBENZONE 3.5g in 100g, OCTINOXATE 6g in 100g, TITANIUM DIOXIDE 5g in 100g
Labeler: J. A. Cosmetics U.S. INC
NDC Code: 76354-015

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 Fact

Active Ingredient:

Benzophenone-3: 3.5%

Octyl methoxycinnamate: 6%

Titanium Dioxide: 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 and skin aging.

Do not use on damaged or broken skin.

When Using This Product:

Avoid contact with eyes. Rinse  with water to remove.

Stop use and ask a doctor if rash occurs

Keep Out Of Reach Of Children

Directions:

Apply generally 15 minutes prior to sun exposure.

Apply to clean skin in an upward and outward motion with a makeup sponge or foundation brush

Children under six months of age: ask a doctor.

Reapply at least every two hours

Use a water resistant sunscreen if swimming or sweating


Other Information

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

Inactive Ingredient:

Water, Mineral Oil, Cyclomethicone, C12-15 Akyl Benzoate, Propylene Glycol, Dimethicone, Steareth-21, Cetearyl Alcohol, Ceteareth-2, Glyceryl Stearate, Xanthan Gum, Methylparaben, Propylparaben, Tocopherol (VE), Retinyl Acetate (VA), Ascorbyl Palmitate (VC), Aloe Barbadensis (Aloe Vera) Leaf Juice, Cucumis Sativus (Cucumber) Fruit Extract

May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)


lab

ELF TINTED MOISTURIZER SPF 20 
oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (OXYBENZONE) OXYBENZONE3.5 g  in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE6 g  in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
CYCLOMETHICONE 
ALKYL (C12-15) BENZOATE 
DIMETHICONE 
STEARETH-21 
WATER38.83 g  in 100 g
CETOSTEARYL ALCOHOL 
CETEARETH-25 
GLYCERYL MONOSTEARATE 
XANTHAN GUM 
METHYLPARABEN 
PROPYLPARABEN 
ALPHA-TOCOPHEROL 
VITAMIN A PALMITATE 
ASCORBYL PALMITATE 
ALOE VERA LEAF 
CUCUMBER JUICE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
PROPYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:76354-015-0125 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/10/2011
Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIOperations
Shanghai J. A. Cosmetics Trading CO., LTD.421280183manufacture

Revised: 04/2012
 
J. A. Cosmetics U.S. INC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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