Drug Facts

Active Ingredients

Zinc Oxide 10.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

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 right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
Use water resistant sunscreen if swimming or sweating.
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Board Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun especially from 10 a.m.-2 p.m., wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: ask a doctor.

Other Information

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

InactiveIngredients

Polyisobutene, Pentaerythrityl Tetraethylhexanoate, Hydrogenated Polysiobutene, C12-15 Alkyl Benzoate, Octyldodecanol, Microcrystalline Wax (Cera Microcristallina), Butyloctyl Salicylate, Tridecyl Trimellitate, Silica Dimethyl Silylate, Oryzanol, Camellia Oleifera Seed Oil, Triethoxycaprylylsilane, Fragrance (Parfum), Ethylhexylglycerin, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Tocopheryl Acetate, Ricinus Communis (Castor) Seed Oil, Isostearic Acid, Sodium Hyaluronate, Polyglyceryl-3 Polyricinoleate, Lecithin, Hydrogenated Castor Oil, Tocopherol [+/-]: Iron Oxide (CI 77491), Titanium Dioxide (CI 77891), Iron Oxide (CI 77492), Iron Oxide (CI 77499), Blue 1 Lake (CI 42090), Red 7 Lake (CI 15850)

Questions?

1-888-315-9814

Package Labeling:

Outer Package Inner Package

E L F SUN BOSS GLOSS SPF 25 SUNSCREEN ITS YOUR MAUVE
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76354-129
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
OCTYLDODECANOL (UNII: 461N1O614Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ORYZANOL (UNII: SST9XCL51M)
CAMELLIA OIL (UNII: T1PE06G0VE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CASTOR OIL (UNII: D5340Y2I9G)
ISOSTEARIC ACID (UNII: X33R8U0062)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 6 (UNII: 481744AI4O)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76354-129-01	1 in 1 CARTON	02/15/2024
1		4 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	02/15/2024

Labeler - e.l.f. Cosmetics, Inc. (093902816)

e.l.f Sun Boss Gloss SPF 25 Sunscreen It’s your Mauve