Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 92a1d6ce-aff3-45fc-8d98-20c4375aded8
Route
TOPICAL
Published
Effective Date 2025-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (80 mg) Ethylhexyl Salicylate (50 mg) Dimethicone (10 mg) Octocrylene (70 mg) Zinc Oxide
Inactive Ingredients
Water Glycerin Propanediol Butyloctyl Salicylate Petrolatum Panthenol Butyrospermum Parkii (shea) Butter Steareth-20 Powdered Cellulose Ethylhexyl Methoxycrylene Polymnia Sonchifolia Root Juice Oryza Sativa (rice) Bran Steareth-2 Sorbitan Isostearate Madecassoside Triethoxycaprylylsilane Alpha-glucan Oligosaccharide Mannose Ammonium Polyacryloyldimethyl Taurate Hydroxyacetophenone Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Hydroxyethylcellulose Caprylyl Glycol Citric Acid Trisodium Ethylenediamine Disuccinate Lactobacillus Maltodextrin Pentylene Glycol Polyhydroxystearic Acid Stearate Polysorbate 60 Chlorphenesin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-01

Description

Dimethicone 1% Homosalate 8% Octisalate 5% Octocrylene 5% Zinc oxide 7%

Purpose

Skin protectant Sunscreen Sunscreen Sunscreen Sunscreen


Medication Information

Purpose

Skin protectant

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Description

Dimethicone 1% Homosalate 8% Octisalate 5% Octocrylene 5% Zinc oxide 7%

Uses
  • temporarily protects chapped or cracked skin
  • 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
Section 51945-4

Warnings

For external use only

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating.
  • 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
Do Not Use

on damaged or broken skin

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

Dimethicone 1%

Homosalate 8%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

Inactive Ingredients

water, glycerin, propanediol, butyloctyl salicylate, petrolatum, panthenol, dimethicone, butyrospermum parkii (shea) butter, steareth-20, cellulose, ethylhexyl methoxycrylene, polymnia sonchifolia root juice, oryza sativa (rice) bran wax, steareth-2, sorbitan isostearate, madecassoside, triethoxycaprylylsilane, alpha-glucan oligosaccharide, mannose, ammonium polyacryloyldimethyl taurate, hydroxyacetophenone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, lactobacillus, maltodextrin, pentylene glycol, polyhydroxystearic acid, polysorbate 60, C12-22 alkyl acrylate/hydroxyethyl acrylate copolymer, chlorphenesin

Questions Or Comments?

1-888-LRP-LABO 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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.


Structured Label Content

Uses
  • temporarily protects chapped or cracked skin
  • 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
Section 51945-4 (51945-4)

Purpose

Skin protectant

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Warnings

For external use only

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating.
  • 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
Do Not Use (Do not use)

on damaged or broken skin

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

Dimethicone 1%

Homosalate 8%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, propanediol, butyloctyl salicylate, petrolatum, panthenol, dimethicone, butyrospermum parkii (shea) butter, steareth-20, cellulose, ethylhexyl methoxycrylene, polymnia sonchifolia root juice, oryza sativa (rice) bran wax, steareth-2, sorbitan isostearate, madecassoside, triethoxycaprylylsilane, alpha-glucan oligosaccharide, mannose, ammonium polyacryloyldimethyl taurate, hydroxyacetophenone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, lactobacillus, maltodextrin, pentylene glycol, polyhydroxystearic acid, polysorbate 60, C12-22 alkyl acrylate/hydroxyethyl acrylate copolymer, chlorphenesin

Questions Or Comments? (Questions or comments?)

1-888-LRP-LABO 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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 Center right away.


Advanced Ingredient Data


Raw Label Data

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