E.L.F INVISIBLE SUNSCREEN SPF 35- avobenzone, octisalate, octocrylene, homosalate cream

e.l.f Invisible Sunscreen SPF 35 by

Drug Labeling and Warnings

e.l.f Invisible Sunscreen SPF 35 by is a Otc medication manufactured, distributed, or labeled by e.l.f. Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3.0%

Octisalate 5.0%

Octocrylene 8.0%

Homosalate 7.0%

Purpose

Sunscreen

Use

• 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 generously and evenly 15 minutes before sun exposure.
• Reapply:
• after 80 minutes of swimming or sweating.
• immediately after towel drying.
• at least every 2 hours.
• 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 Broad 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: Ask a doctor. 

Other Information

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

Inactive Ingredients

Isododecane, Dimethicone, Silica Dimethyl Silylate, Caprylyl Methicone, PEG-10 Dimethicone/Vinyl Dimethicone Crosspolymer, Glycerin, PEG-12 Dimethicone/PPG-20 Crosspolymer, Pongamia Pinnata Seed Extract, Limnanthes Alba (Meadowfoam) Seed Oil, Aloe Barbadensis Leaf Juice Powder, Polyester-7, Neopentyl Glycol Diheptanoate, Phenoxyethanol, Ethylhexylglycerin, Isopropyl Palmitate

Question or comments?

1-888-315-9814

Package Labeling:50ml

Package Labeling:10ml

INGREDIENTS AND APPEARANCE

E.L.F INVISIBLE SUNSCREEN SPF 35 
avobenzone, octisalate, octocrylene, homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-444
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYESTER-7 (UNII: 0841698D2F)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-444-01	1 in 1 CARTON	02/15/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 76354-444-02	1 in 1 CARTON	02/15/2023
2		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/15/2023

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