ELF Tinted Moisturizer SPF 20 by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD. Drug Fact

ELF Tinted Moisturizer SPF 20 by

Drug Labeling and Warnings

ELF Tinted Moisturizer SPF 20 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 20 - 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: 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-015
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	6 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
CYCLOMETHICONE (UNII: NMQ347994Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)	38.83 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARETH-25 (UNII: 8FA93U5T67)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMBER JUICE (UNII: 61845009SP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-015-01	25 g in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2011	12/31/2017

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

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

Revised: 4/2012

Document Id: a1a91b14-c637-44c8-876a-36c0757cc604

34390-5

Set id: 37307ff7-183d-4d60-97ae-4ffe10f972b2

Version: 3

Effective Time: 20120418

 

J. A. Cosmetics U.S. INC