OTC Medication Information: La Roche Posay Laboratoire Dermatologique Anthelios AOX Daily Antioxidant Serum Broad Spectrum SPF 50 Sunscreen

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS AOX DAILY ANTIOXIDANT SERUM BROAD SPECTRUM SPF 50 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.

Active ingredient

Avobenzone 2.68%

Homosalate 9.6%

Octisalate 2.88%

Octocrylene 5.38%

Oxybenzone 3.46%

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:

• shake well before 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, dimethicone, cyclopentasiloxane, tocopherol, acrylates/dimethicone copolymer, phenoxyethanol, propylene glycol, caprylyl glycol, silica, sodium polyacrylate, ascorbyl glucoside, scutellaria baicalensis root extract, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, diethylhexyl syringylidenemalonate, polyacrylamide, C13-14 isoparaffin, laureth-7, cassia alata leaf extract, maltodextrin, triethanolamine

Questions or comments?

1-888-LRP-LABO 1-888-577-5226

Monday — Friday (9 a.m. — 5 p.m. EST)

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS AOX DAILY ANTIOXIDANT SERUM BROAD SPECTRUM SPF 50 SUNSCREEN avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-370 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (AVOBENZONE) AVOBENZONE 26.8 mg in 1 mL HOMOSALATE (HOMOSALATE) HOMOSALATE 96 mg in 1 mL OCTISALATE (OCTISALATE) OCTISALATE 28.8 mg in 1 mL OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 53.8 mg in 1 mL OXYBENZONE (OXYBENZONE) OXYBENZONE 34.6 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER DIMETHICONE TOCOPHEROL PHENOXYETHANOL PROPYLENE GLYCOL CAPRYLYL GLYCOL ASCORBYL GLUCOSIDE LAURETH-7 MALTODEXTRIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:49967-370-01 1 BOTTLE in 1 CARTON contains a BOTTLE 1 30 mL in 1 BOTTLE This package is contained within the CARTON (49967-370-01) 2 NDC:49967-370-02 3 mL in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2015

Labeler — L’Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Operations
L’Oreal USA, Inc.		185931458	manufacture (49967-370)

Establishment
Name	Address	ID/FEI	Operations
Goodier Cosmetics LLC		007317209	pack (49967-370)

Revised: 09/2020 L’Oreal USA Products Inc