LA ROCHE POSAY ANTHELIOS UV AIR SERUM SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate and octocrylene liquid

La Roche Posay Anthelios UV Air Serum Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

La Roche Posay Anthelios UV Air Serum Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA PRODUCTS, INC., Unette Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 7%

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

For sunscreen use:

● apply generously 15 minutes before sun exposure

● reapply at least every 2 hours

● use a 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 Broad Spectrum SPF value 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-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

Inactive ingredients

water, glycerin, C15-19 alkane, niacinamide, propanediol, C12-22 alkyl acrylate/hydroxyethylacrylate copolymer, tocopherol, caprylic/ capric triglyceride, caprylyl glycol, cassia alata leaf extract, cetearyl alcohol, citric acid, diethylhexyl syringylidenemalonate, glyceryl stearate, helianthus annuus (sunflower) seed wax, hydroxyacetophenone, hydroxypropyl starch phosphate, jojoba esters, maltodextrin, pentylene glycol, polyglycerin-3, sclerotium gum, sodium hyaluronate, sodium hydroxide, sodium starch octenylsuccinate, sodium stearoyl glutamate, trisodium ethylenediamine disuccinate

Questions or comments?

1-888-LRP-LAB0 1-888-577-5226

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY ANTHELIOS UV AIR SERUM SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate and octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82046-114
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
C15-19 ALKANE (UNII: CI87N1IM01)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPANEDIOL (UNII: 5965N8W85T)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID (UNII: 2968PHW8QP)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
HYDROLYZED JOJOBA ESTERS (UNII: UDR641JW8W)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
SCLEROTIUM GUM (UNII: 2X51AD1X3T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82046-114-01	1 in 1 CARTON	12/01/2025
1		50 mL in 1 BOTTLE; 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	12/01/2025

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(82046-114) , pack(82046-114)

Establishment
Name	Address	ID/FEI	Business Operations
Unette Corporation		011401882	pack(82046-114)