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

ELF Beauty Shield SPF 50 Skin Shielding Primer by

Drug Labeling and Warnings

ELF Beauty Shield SPF 50 Skin Shielding Primer by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Zinc Oxide: 25.0%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

Helps prevent sunburn

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

WARNINGS

Warning:

For external use only

Do not use on damaged or broken skin

WHEN USING

When using this product:

Keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop Use and Ask a Doctor if:

Rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children

DOSAGE & ADMINISTRATION

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

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ELF BEAUTY SHIELD SPF 50 SKIN SHIELDING PRIMER 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-804
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-804-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2017	01/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/26/2017	01/12/2021

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