LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS GLOW DAILY GLOW SUNSCREEN BRONZE CELL OX SHIELD BROAD SPECTRUM SPF 35- avobenzone, homosalate, octisalate and octocrylene liquid

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 13%

Octisalate 5%

Octocrylene 6%

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
• store at 20oC - 25oC (68oF - 77oF)

Inactive ingredients

water, glycerin, dicaprylyl carbonate, alcohol denat., C12-22 alkyl acrylate/ hydroxyethylacrylate copolymer, dimethicone, silica, synthetic fluorphlogopite, zea mays (corn) starch, mica, iron oxides, phenoxyethanol, titanium dioxide, dimethicone/PEG-10/15 crosspolymer, hydroxyacetophenone, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, acrylamide/sodium acryloyldimethyltaurate copolymer, xanthan gum, arachidyl alcohol, chlorphenesin, caprylyl glycol, isohexadecane, behenyl alcohol, tocopherol, pentylene glycol, tetrasodium glutamate diacetate, diethylhexyl syringylidenemalonate, trisodium ethylenediamine disuccinate, arachidyl glucoside, citric acid, polysorbate 80, ammonium polyacryloyldimethyl taurate, cassia alata leaf extract, maltodextrin, sorbitan oleate, dipropylene glycol, glycine soja (soybean) oil, caprylic/capric triglyceride, tin oxide, disodium stearoyl glutamate, sodium citrate, aluminum hydroxide

Questions or comments?

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

Monday - Friday (9 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS GLOW DAILY GLOW SUNSCREEN BRONZE CELL OX SHIELD BROAD SPECTRUM SPF 35 
avobenzone, homosalate, octisalate and octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82046-768
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	130 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICA (UNII: ETJ7Z6XBU4)
ZEA MAYS (CORN) STARCH (UNII: O8232NY3SJ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)
ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (120000 MPA.S AT 1%) (UNII: 5F4963KLHS)
XANTHAN GUM (UNII: TTV12P4NEE)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
CHLORPHENESIN (UNII: I670DAL4SZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOHEXADECANE (UNII: 918X1OUF1E)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
CITRIC ACID (UNII: 2968PHW8QP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SORBITAN OLEATE (UNII: 06XEA2VD56)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SOYBEAN OIL (UNII: 241ATL177A)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
TIN OXIDE (UNII: KM7N50LOS6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82046-768-01	1 in 1 CARTON	04/28/2026
1		40 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	04/28/2026

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(82046-768)

Establishment
Name	Address	ID/FEI	Business Operations
Unette Corporation		011401882	pack(82046-768)