ELF TINTED MOISTURIZER SPF-20- octinoxate, oxybenzone and 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

Other Information

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

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: Iron Oxides (CI 77491, CI 77492, CI 77499)

83221-8 tinted moisturizer_0808_Cropped

ELF TINTED MOISTURIZER  SPF-20
octinoxate, oxybenzone, octisalate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76354-112
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE3   in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
MINERAL OIL 
PROPYLENE GLYCOL 
C12-15 ALKYL BENZOATE 
MEDIUM-CHAIN TRIGLYCERIDES 
STEARETH-21 
DIMETHICONE 
STEARETH-2 
CETOSTEARYL ALCOHOL 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
XANTHAN GUM 
POLYACRYLAMIDE (10000 MW) 
C13-14 ISOPARAFFIN 
LAURETH-7 
DMDM HYDANTOIN 
IODOPROPYNYL BUTYLCARBAMATE 
VITAMIN A PALMITATE 
.ALPHA.-TOCOPHEROL ACETATE 
MAGNESIUM ASCORBYL PHOSPHATE 
ALOE VERA LEAF 
CUCUMBER 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76354-112-511 in 1 BOX
1NDC:76354-112-1125 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/26/2014
Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai J. A. Cosmetics Trading CO., LTD.421280183manufacture(76354-112)

Revised: 8/2014
Document Id: 50146835-75c7-45a7-a03f-47b481c5c8ab
Set id: f793c4c5-2270-483b-818d-c16b7ebfe836
Version: 1
Effective Time: 20140826
 
J. A. Cosmetics U.S. INC