la roche-posay anthelios spray lotion sunscreen spf 60 ultra light

la roche-posay anthelios spray lotion sunscreen spf 60 ultra light
SPL v2
SPL
SPL Set ID dad00eee-92cd-7610-e053-2a95a90a1fac
Route
topical
Published
Effective Date 2022-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (27 mg) homosalate (96 mg) octisalate (29 mg) octocrylene (54 mg) oxybenzone (35 mg)
Inactive Ingredients
water dimethicone isopropyl lauroyl sarcosinate glycerin isotridecyl isononanoate caprylyl trisiloxane octyldodecanol phenoxyethanol propylene glycol caprylyl glycol sodium stearoyl glutamate polysorbate 61 glyceryl monostearate peg-8 laurate octyldodecyl xyloside peg-12 dimethicone (300 cst) p-anisic acid stearyl alcohol edetate disodium anhydrous tocopherol diethylhexyl syringylidenemalonate senna alata leaf maltodextrin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2014-01-01

Purpose

Sunscreen

Description

Avobenzone 2.7% Homosalate 9.6% Octisalate 2.9% Octocrylene 5.4% Oxybenzone 3.5%


Medication Information

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Direction
Purpose

Sunscreen

Directions

For sunscreen use:   

  • spray generously and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from 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
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly  use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • 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

Description

Avobenzone 2.7% Homosalate 9.6% Octisalate 2.9% Octocrylene 5.4% Oxybenzone 3.5%

Do Not Use

on damaged or broken skin

Package Labeling:

Active Ingredients

Avobenzone 2.7%

Homosalate 9.6%

Octisalate 2.9%

Octocrylene 5.4%

Oxybenzone 3.5%

Questions Or Comments?

Monday - Friday (9 a.m. - 5 p.m. EST) 1-888-LRP-LAB0 1-888-577-5226

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

Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F. Avoid spraying in eyes.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Direction
Purpose

Sunscreen

Directions

For sunscreen use:   

  • spray generously and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from 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
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly  use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • 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 (Other information)
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients (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

Do Not Use (Do not use)

on damaged or broken skin

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 2.7%

Homosalate 9.6%

Octisalate 2.9%

Octocrylene 5.4%

Oxybenzone 3.5%

Questions Or Comments? (Questions or comments?)

Monday - Friday (9 a.m. - 5 p.m. EST) 1-888-LRP-LAB0 1-888-577-5226

When Using This Product (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 (Stop use and ask a doctor if)

rash occurs

Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F. Avoid spraying in eyes.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


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