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

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

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

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
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

Other Information
  • protect the product in this container from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

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

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

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

Warnings

For external use only

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
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

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

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

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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