Drug Fact

Drug Fact

Drug Labeling and Warnings

Drug Details

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ELF BEAUTIFULLY BARE FOUNDATION SERUM BROAD SPECTRUM SPF 25 SUNSCREEN MEDIUM DARK- 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: 13.8%

Purpose:

Sunscreen

Uses:

Help prevent sunburn

If used as directed with other sun protection measures, 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

If swallowed, get medical help or contact a poison control center immediately

Directions:

For sunscreen use:

Apply generously 15 min before sun exposure. Reapply 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, Water, Dimethicone, Silica, Isododecane, PEG-10 Dimethicone, Acrylates/Dithicone Copolymer, PEG-9 Dimethylsiloxyethyl Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Chloride, Quaternium-18, Bentonite, Dimethicone/PEG-10/15 Crosspolymer, Propylene Carbonate, Triethoxycaprylsilane, Talc, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Pentaerythrityl Tetraisosterate, Paraffinum Liquidum (Mineral Oil), Disteardimonium Hectorite, Palmitoyl Tripeptide-1, Punica Granatum Seed Oil, Vitis Vinifera (Grape) Seed Oil, Retinyl Palmitate (Va), Tocopheryl Acetate (Ve), Ascorbyl Palmitate (Vc), Lycium Barbarum Fruit Extract

May contain:

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

label

ELF BEAUTIFULLY BARE FOUNDATION SERUM BROAD SPECTRUM SPF 25 SUNSCREEN MEDIUM DARK 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76354-619
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION13.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DISODIUM HEDTA (UNII: KME849MC7A)  
SODIUM CHLORATE (UNII: T95DR77GMR)  
QUATERNIUM-18 (UNII: O7757NO1VL)  
BENTONITE (UNII: A3N5ZCN45C)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MINERAL OIL (UNII: T5L8T28FGP)  
TALC (UNII: 7SEV7J4R1U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76354-619-0114 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/201512/05/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/10/201512/05/2019
Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 10/2015
 
J. A. Cosmetics U.S. INC


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