LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 DAILY ANTIAGING PRIMER WITH SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
L'Oreal USA Products 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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Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Oxybenzone 6%

Uses

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:


Purpose

Sunscreen

Other information

Inactive ingredients

dimethicone, C12-15 alkyl benzoate, talc, diisopropyl sebacate, silica, silica silylate, glycerin, trimethylsiloxysilicate, dimethicone crosspolymer, water, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

Questions or comments?

1-888-LRP-LABO  1-888-577-5226

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

image of a carton

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 DAILY ANTIAGING PRIMER WITH SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-095
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 100 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 60 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TALC (UNII: 7SEV7J4R1U)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
WATER (UNII: 059QF0KO0R)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49967-095-01 1 in 1 CARTON 04/05/2012
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 not final part352 04/05/2012
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Business Operations
L'Oreal USA Products Inc 185931458 manufacture(49967-095)

Revised: 8/2019
Document Id: f49daac0-a750-4264-b42d-d71df7706d1a
Set id: 6b65d6d9-7ff3-4c84-986e-ef180161eadb
Version: 2
Effective Time: 20190820
L'Oreal USA Products Inc