OTC Medication Information: La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
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 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.
  • keep away from face to avoid breathing it

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:

● spray generously and spread evenly by hand 15 minutes before sun exposure

● hold container 4 to 6 inches from the skin to apply

● do not spray directly into face. Spray on hands then apply to face.

● do not apply in windy conditions

● use in a well-ventilated area

● 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, dimethicone, isopropyl lauroyl sarcosinate, glycerin, styrene/acrylates copolymer, isotridecyl isononanoate, polyurethane-35, caprylyl methicone, octyldodecanol, phenoxyethanol, propylene glycol, caprylyl glycol, sodium stearoyl glutamate, polysorbate 61, glyceryl stearate, PEG-8 laurate, dimethiconol, octyldodecyl xyloside, PEG-12 dimethicone, p-anisic acid, stearyl alcohol, disodium EDTA, tocopherol, 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 ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES
avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-008
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (Avobenzone) Avobenzone 26.8 mg in 1 g
Homosalate (Homosalate) Homosalate 96 mg in 1 g
Octisalate (Octisalate) Octisalate 28.8 mg in 1 g
Octocrylene (Octocrylene) Octocrylene 53.8 mg in 1 g
Oxybenzone (Oxybenzone) Oxybenzone 34.6 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
DIMETHICONE
ISOPROPYL LAUROYL SARCOSINATE
GLYCERIN
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)
ISOTRIDECYL ISONONANOATE
CAPRYLYL TRISILOXANE
OCTYLDODECANOL
PHENOXYETHANOL
PROPYLENE GLYCOL
CAPRYLYL GLYCOL
SODIUM STEAROYL GLUTAMATE
POLYSORBATE 61
GLYCERYL MONOSTEARATE
PEG-8 LAURATE
DIMETHICONOL (2000 CST)
OCTYLDODECYL XYLOSIDE
PEG-12 DIMETHICONE
p-ANISIC ACID
STEARYL ALCOHOL
EDETATE DISODIUM
TOCOPHEROL
DIETHYLHEXYL SYRINGYLIDENEMALONATE
SENNA ALATA LEAF
MALTODEXTRIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-008-01 143 g in 1 BOTTLE, SPRAY 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
American Spraytech, LLC 137135237 manufacture (49967-008)
Establishment
Name Address ID/FEI Operations
L’Oreal USA, Inc. 185931458 manufacture (49967-008)

Revised: 01/2022 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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