ELF BEAUTY SHIELD SPF 50 SKIN SHIELDING PRIMER- zinc oxide 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:

Zinc Oxide: 25.0%

Purpose:

Sunscreen

Uses:

Helps prevent sunburn

If used as directed (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warning:

For external use only

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:

For suncreen use:

Apply liberally 15 min before sun exposure.

Reapply at least every two hours.

Use a water resistant sunscreen if swimming or sweating

Sun Protection Measures:

Spending time in sun increases your risk of skin cancer or early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including

  • Limit time in the sun, especially from 10 am to 2 pm
  • Wear long sleeved shirts, pants, hats, and sunglasses.
  • Children under six months of age: ask a doctor

Other Information:

Protect this product in the container from excessive heat and direct sun

Inactive Ingredient:

Cyclopentasiloxane,Triethoxycaprylylsilane, Cyclohexasiloxane, Wayer, Dimethicone Crosspolymer, Cetyl PEG/PEG-10/1 Dimethicone, Silica, Silica Dimethyl Silylate, Tocopherol Acetate (VE), Daucus Carota Sativa (Carrot) Root Extract, Daucus Carota Sativa (Carrot) Seed Oil, Beta Carotene, Helianthus Annuus (Sunflower) Seed Oil, Ascorbyl Palmitate (VC), Glyceryl Stearate, Stearic Acid, Fragrance, Phenoxyethanol, Ethylhexylglycerin, Sodium Chloride

May contain:

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

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ELF BEAUTY SHIELD SPF 50 SKIN SHIELDING PRIMER 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-804
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CARROT JUICE (UNII: QXF936IX43)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CARROT SEED OIL (UNII: 595AO13F11)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
STEARIC ACID (UNII: 4ELV7Z65AP) 5.0 g  in 100 mL
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76354-804-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/201701/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/26/201701/12/2021
Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 5/2017
 
J. A. Cosmetics U.S. INC