LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV TONE BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion

La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA Products, Inc. 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
· reaply 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 the 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, sodium stearoyl glutamate, cetearyl alcohol, sclerotium gum, hydroxyacetophenone, caprylyl glycol, sodium starch octenylsuccinate, glyceryl stearate, jojoba esters, helianthus annuus (sunflower) seed wax, hydroxypropyl starch phosphate, trisodium ethylenediamine disuccinate, pentylene glycol, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin, sodium hydroxide, caprylic/capric triglyceride, polyglycerin-3, citric acid

Questions or comments?

1-888- LRP-LABO  1-888-577-5226

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV TONE BROAD SPECTRUM SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-212
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) (ETHYLHEXYL SALICYLATE - 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)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
SCLEROTIUM GUM (UNII: 2X51AD1X3T)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
HYDROLYZED JOJOBA ESTERS (UNII: UDR641JW8W)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-212-01	1 in 1 CARTON	01/11/2024
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-212-02	15 in 1 PACKAGE	01/11/2024
2		5 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	01/11/2024

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products, Inc		624244349	manufacture(49967-212)