ELF Tinted Moisturizer SPF 15 by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD. Drug Fact

ELF Tinted Moisturizer SPF 15 by

Drug Labeling and Warnings

ELF Tinted Moisturizer SPF 15 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 TINTED MOISTURIZER SPF 15 - oxybenzone 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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Drug Fact

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)

labe

ELF TINTED MOISTURIZER SPF 15 
oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
KAOLIN (UNII: 24H4NWX5CO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WHITE WAX (UNII: 7G1J5DA97F)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLPARABEN (UNII: 14255EXE39)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)	42.35 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-006-01	12 g in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2011	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/09/2011	12/31/2017

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

Revised: 4/2012

Document Id: 64e6809e-50ae-45ed-8973-9340f31ccef8

34390-5

Set id: ca491291-174b-47fd-ad9a-751baa420ad2

Version: 3

Effective Time: 20120418

 

J. A. Cosmetics U.S. INC