basics d33.000/d33aa

basics d33.000/d33aa
SPL v5
SPL
SPL Set ID 03fce792-bcbb-4848-bc87-8913ecbe0786
Route
topical
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (120 mg) octisalate (50 mg)
Inactive Ingredients
dimethicone/peg-10/15 crosspolymer ethylhexyl stearate glycerin edetate disodium anhydrous .alpha.-tocopherol acetate butylated hydroxytoluene trideceth-6 pentylene glycol benzyl benzoate water diethylhexyl 2,6-naphthalate glyceryl monostearate styrene/acrylamide copolymer (500000 mw) silicon dioxide butyloctyl salicylate peg-100 stearate dimethicone potassium cetyl phosphate benzyl alcohol yellow wax caprylyl trisiloxane cetyl dimethicone 150 aluminum starch octenylsuccinate docosanol butyl acrylate/c16-c20 alkyl methacrylate/methacrylic acid/methyl methacrylate copolymer xanthan gum sodium polyacrylate (8000 mw) chlorphenesin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-12-27

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 12% Octisalate 5%


Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

Directions
  • apply liberaly 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especialy 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, diethylhexyl 2,6-naphthalate, styrene/acrylates copolymer, silica, butyloctyl salicylate, glyceryl stearate, PEG-100 stearate, dimethicone, potassium cetyl phosphate, benzyl alcohol, beeswax, caprylyl methicone, cetyl dimethicone, aluminum starch octenylsuccinate, behenyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, xanthan gum, sodium polyacrylate, chlorphenesin, dimethicone/PEG-10/15 crosspolymer, fragrance, ethylhexyl stearate, glycerin, disodium EDTA, tocopheryl acetate, BHT, trideceth-6, pentylene glycol, benzyl benzoate

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

Do Not Use
  • on damaged or broken skin
Disclaimers

*This product is not manufacturedor distributed by Kenvue, Inc., distributor of Neutrogena ®Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 55.

May stain or damage some fabrics or surfaces.

Adverse Reaction

Dist. by: Amazon.com Services, LLC

Seattle, WA 98109 1-877-485-0385

© 2023 Amazon.com, Inc or its affiliates. All rights reserved.

www.amazon.com/amazonbasics

Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

Principal Panel Display

amazon basics

sheer touch

sunscreen lotion

Broad Spectrum SPF 55

Water Resistant (80 minutes)

Dermatologist Tested

Formulated Without Octinoxate, Oxybenzone, & Octocrylene

Compare to Neutrogena ® Ultra Sheer ® Sunscreen Broad Spectrum SPF 55*

SPF 55

3 FL OZ (88 mL)

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 right away.


Structured Label Content

Warnings

For external use only

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
Purpose

Sunscreen

Directions
  • apply liberaly 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especialy 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, diethylhexyl 2,6-naphthalate, styrene/acrylates copolymer, silica, butyloctyl salicylate, glyceryl stearate, PEG-100 stearate, dimethicone, potassium cetyl phosphate, benzyl alcohol, beeswax, caprylyl methicone, cetyl dimethicone, aluminum starch octenylsuccinate, behenyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, xanthan gum, sodium polyacrylate, chlorphenesin, dimethicone/PEG-10/15 crosspolymer, fragrance, ethylhexyl stearate, glycerin, disodium EDTA, tocopheryl acetate, BHT, trideceth-6, pentylene glycol, benzyl benzoate

Do Not Use (Do not use)
  • on damaged or broken skin
Disclaimers

*This product is not manufacturedor distributed by Kenvue, Inc., distributor of Neutrogena ®Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 55.

May stain or damage some fabrics or surfaces.

Adverse Reaction

Dist. by: Amazon.com Services, LLC

Seattle, WA 98109 1-877-485-0385

© 2023 Amazon.com, Inc or its affiliates. All rights reserved.

www.amazon.com/amazonbasics

Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

Principal Panel Display (Principal panel Display)

amazon basics

sheer touch

sunscreen lotion

Broad Spectrum SPF 55

Water Resistant (80 minutes)

Dermatologist Tested

Formulated Without Octinoxate, Oxybenzone, & Octocrylene

Compare to Neutrogena ® Ultra Sheer ® Sunscreen Broad Spectrum SPF 55*

SPF 55

3 FL OZ (88 mL)

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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