OTC Medication Information: La Roche Posay Laboratoire Dermatologique Anthelios Broad Spectrum SPF 100 Body and Face Melt In Milk Sunscreen Water Resistant 80 Minutes

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS BROAD SPECTRUM SPF 100 BODY AND FACE MELT IN MILK SUNSCREEN WATER RESISTANT 80 MINUTES- avobenzone, homosalate, octisalate and octocrylene 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 ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

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, polymethylsilsesquioxane, glycerin, dimethicone, poly c10-30 alkyl acrylate, styrene/acrylates copolymer, silica, caprylyl methicone, acrylates/dimethicone copolymer, diethylhexyl syringylidenemalonate, PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl phosphate, tocopherol, caprylyl glycol, panthenol, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, PEG-8 laurate, inulin lauryl carbamate, chlorphenesin, p-anisic acid, caprylic/capric triglyceride, xanthan gum, disodium EDTA, cassia alata leaf extract, maltodextrine, sodium dodecylbenzenesulfonate

Questions or comments?

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

Monday — Friday (9 a.m. — 5 p.m. EST)

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LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS BROAD SPECTRUM SPF 100 BODY AND FACE MELT IN MILK SUNSCREEN WATER RESISTANT 80 MINUTES
avobenzone, homosalate, octisalate and octocrylene lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-103
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 150 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
GLYCERIN
DIMETHICONE
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)
SILICON DIOXIDE
CAPRYLYL TRISILOXANE
DIETHYLHEXYL SYRINGYLIDENEMALONATE
PEG-100 STEARATE
GLYCERYL MONOSTEARATE
PHENOXYETHANOL
POTASSIUM CETYL PHOSPHATE
TOCOPHEROL
CAPRYLYL GLYCOL
PANTHENOL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
TROLAMINE
PEG-8 LAURATE
CHLORPHENESIN
P-ANISIC ACID
MEDIUM-CHAIN TRIGLYCERIDES
XANTHAN GUM
EDETATE DISODIUM
SENNA ALATA LEAF
MALTODEXTRIN
SODIUM DODECYLBENZENESULFONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-103-01 1 TUBE in 1 CARTON contains a TUBE
1 90 mL in 1 TUBE This package is contained within the CARTON (49967-103-01)
2 NDC:49967-103-02 1 TUBE in 1 CARTON contains a TUBE
2 5 mL in 1 TUBE This package is contained within the CARTON (49967-103-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/01/2020
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
L’OREAL USA PRODUCTS, INC. 624244349 manufacture (49967-103), pack (49967-103)

Revised: 01/2021 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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