ELF SPF 45 Sunscreen UVA/UVB Protection by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD. Drug Fact

ELF SPF 45 Sunscreen UVA/UVB Protection by

Drug Labeling and Warnings

ELF SPF 45 Sunscreen UVA/UVB Protection by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai J. A. Cosmetics Trading CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION - titanium dioxide 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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Drug Fact

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)

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ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23.3 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18.7 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)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-016-01	10 g in 1 BOTTLE; Type 0: Not a Combination Product	10/22/2011	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/22/2011	12/31/2017

Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 4/2012

Document Id: e8fb6c31-6feb-4f31-a272-9cbcb04b2bae

34390-5

Set id: f5077133-ada2-4df2-bf51-7e4ff30fc86f

Version: 3

Effective Time: 20120418