ELF TINTED MOISTURIZER by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD.

ELF TINTED MOISTURIZER by

Drug Labeling and Warnings

ELF TINTED MOISTURIZER 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- octinoxate, oxybenzone, octisalate 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:

OCTINOXATE: 7.5%

OCTISALATE: 5%

OXYBENZONE: 3%

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.

DO NOT USE ON DAMAGED OR BROKEN SKIN.

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 generously 15 minutes before sun exposure.
• Apply to clean skin in an upward and outward motion with Makeup Sponge or Foundation Brush.
• Children under 6 months of age; ask a doctor.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating

SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SUN CANCER AND EARLY AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH BROAD SPECTRUM SPF VALUE OF  15 OR HIGHER AND OTHER SUN PROTECTION INCLUDING:

• LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M.
• WEAR LONG-SLEEVED SHIRT, PANTS, HATS AND SUNGLASSES.
• CHILDREN UNDER 6 MONTHS OF AGE: ASK DOCTOR.

Other Information

• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

Inactive Ingredient:

WATER (AQUA), PARAFFINUM LIQUIDUM (MINERAL OIL), PROPYLENE GLYCOL, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, STEARETH-21, DIMETHICONE, STEARETH-2, CETEARYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, XANTHAN GUM, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, DMDM HYDANTOIN, IODOPROPYNYL BUTYLCARBAMATE, RETINYL PALMITATE (VA), TOCOPHERYL ACETATE (VE), MAGNESIUM ASCORBYL PHOSPHATE (VC), ALOE VERA LEAF JUICE, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT

May Contain: TITANIUM DIOXIDE (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

QUESTIONS OR COMMENTS

1-855-353-7320

ELF TINTED MOISTURIZER  SPF-20
octinoxate, oxybenzone, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3   in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARETH-21 (UNII: 53J3F32P58)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARETH-2 (UNII: V56DFE46J5)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMBER (UNII: YY7C30VXJT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-112-51	1 in 1 BOX	08/26/2014	12/31/2017
1	NDC: 76354-112-11	25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/26/2014	12/31/2017

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

Revised: 8/2014

Document Id: 0ee81f49-f2da-44ba-8b94-6ae249d5bd2e

34390-5

Set id: f793c4c5-2270-483b-818d-c16b7ebfe836

Version: 3

Effective Time: 20140828

 

J. A. Cosmetics U.S. INC