OTC Medication Information: La Roche Posay Laboratoire Dermatologique Anthelios 60 Melt In Sunscreen Milk Face and Body Broad Spectrum SPF 60 Water Resistant 80 Minutes

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK FACE AND BODY BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES- 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 3%

Homosalate 10.72%

Octisalate 3.21%

Octocrylene 6%

Oxybenzone 3.86%

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:

● after 80 minutes of swimming or sweating

● immediately after towel drying

● at least every 2 hours

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, styrene/acrylates copolymer, dimethicone, polymethylsilsesquioxane, butyloctyl salicylate, glycerin, alcohol denat., poly C10-30 alkyl acrylate, caprylyl methicone, trisiloxane, acrylates/dimethicone copolymer, PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl phosphate, propylene glycol, caprylyl glycol, PEG-8 laurate, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, tocopherol, inulin lauryl carbamate, disodium EDTA, p-anisic acid, xanthan gum, 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)

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LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK FACE AND BODY BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-864
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 107.2 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 32.1 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 60 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 38.6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DIMETHICONE
BUTYLOCTYL SALICYLATE
GLYCERIN
ALCOHOL
TRISILOXANE
PEG-100 STEARATE
PHENOXYETHANOL
POTASSIUM CETYL PHOSPHATE
PROPYLENE GLYCOL
CAPRYLYL GLYCOL
PEG-8 LAURATE
TOCOPHEROL
P-ANISIC ACID
XANTHAN GUM
MALTODEXTRIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-864-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 150 mL in 1 BOTTLE This package is contained within the CARTON (49967-864-01)
2 NDC:49967-864-02 1 TUBE in 1 CARTON contains a TUBE
2 150 mL in 1 TUBE This package is contained within the CARTON (49967-864-02)
3 NDC:49967-864-03 1 TUBE in 1 CARTON contains a TUBE
3 90 mL in 1 TUBE This package is contained within the CARTON (49967-864-03)
4 NDC:49967-864-04 5 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 01/01/2014
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
L’Oreal USA, Inc. 185931458 manufacture (49967-864)

Revised: 02/2022 L’Oreal USA Products Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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