ELF - SPF 45 Setting Spray (19-SP-029)

E.L.F. All Set For Sun SPF 45 Setting by

Drug Labeling and Warnings

E.L.F. All Set For Sun SPF 45 Setting by is a Otc medication manufactured, distributed, or labeled by E.L.F. Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

E.L.F. ALL SET FOR SUN SPF 45 SETTING- avobenzone, octisalate, octocrylene spray 
E.L.F. Cosmetics, 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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ELF - SPF 45 Setting Spray (19-SP-029)

Avobenzone – 2.9%
Octisalate – 4.9%
Octocrylene – 9.5%

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.

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.

Flammable. Do not spray near heat, sparks, sources of ignition, or flames.

Keep out of reach of children. In case of ingestion, 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months of age: ask a physician.

Other Information

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

Alcohol Denat., Bisabolol, Butyloctyl Salicylate, Capryloyl Glycerin/Sebacic Acid Copolymer, Citrullus Lanatus (Watermelon) Fruit Extract, Dicaprylyl Carbonate, Diheptyl Succinate, Diisooctyl Succinate, Ethyl Ferulate, Helianthus Annuus (Sunflower) Seed Oil, Isododecane, Lauroyl Lysine, Nylon-12, Opuntia Ficus-Indica Seed Oil, PVP, Silica Caprylyl Silylate, Tocopherol

Questions?

1-888-315-9814

Bottle

Carton

E.L.F. ALL SET FOR SUN SPF 45 SETTING 
avobenzone, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
WATERMELON (UNII: 231473QB6R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
LAUROYL LYSINE (UNII: 113171Q70B)
NYLON-12 (UNII: 446U8J075B)
OPUNTIA FICUS-INDICA SEED OIL (UNII: 1XGW49AK2J)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
ALCOHOL (UNII: 3K9958V90M)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
ETHYL FERULATE (UNII: 5B8915UELW)
ISODODECANE (UNII: A8289P68Y2)
TOCOPHEROL (UNII: R0ZB2556P8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCCINIC ACID (UNII: AB6MNQ6J6L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-400-01	1 in 1 CARTON	03/01/2023
1		60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	03/01/2023

Labeler - E.L.F. Cosmetics, Inc. (186705047)

Revised: 3/2023

Document Id: f6de8ec6-d4a5-d788-e053-6394a90aad90

34390-5

Set id: f6de8ec6-d4a4-d788-e053-6394a90aad90

Version: 1

Effective Time: 20230322