Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID a72e6720-2883-401f-84ab-77d898f87b66
Route
TOPICAL
Published
Effective Date 2014-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (15 g) Octisalate (5 g) Octocrylene (10 g) Oxybenzone (6 g)
Inactive Ingredients
Water Glyceryl Monostearate Cellulose, Microcrystalline Butylene Glycol Peg-100 Stearate Benzyl Alcohol Diethylhexyl Syringylidenemalonate Docosanol Palmitic Acid Stearic Acid Carboxymethylcellulose Sodium Tricaprylin Vitamin A Palmitate Tocopherol Sodium Ascorbyl Phosphate Edetate Disodium Chlorphenesin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-03-03
Description

Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0% Oxybenzone 6.0%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0% Oxybenzone 6.0%

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

Section 60561-8
  • May stain some fabrics.

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • 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 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-sleeve 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 this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

Oxybenzone 6.0%



Inactive Ingredients

Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.

Questions Or Comments?

Call 1-503-639-6300



Principal Display Panel

WESTERN FAMILY

Broad Spectrum SPF 70

sunscreen lotion

UVA/UVB protection

moisturizing with vitamin e

water resistant

(80 minutes)

8 FL OZ (236 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 the Reach of Children

If product is swallowed, get medical help or contact a Poison Control Center 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

Section 60561-8 (60561-8)
  • May stain some fabrics.

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • 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 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-sleeve 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 this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

Oxybenzone 6.0%



Inactive Ingredients (Inactive ingredients)

Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.

Questions Or Comments? (Questions or comments?)

Call 1-503-639-6300



Principal Display Panel

WESTERN FAMILY

Broad Spectrum SPF 70

sunscreen lotion

UVA/UVB protection

moisturizing with vitamin e

water resistant

(80 minutes)

8 FL OZ (236 mL)







When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs



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

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



Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:45.740091 · Updated: 2026-03-14T22:53:42.713163