Broad Spectrum Spf15 Very Water Resistant (80 Minutes) Sunscreen

Broad Spectrum Spf15 Very Water Resistant (80 Minutes) Sunscreen
SPL v2
SPL
SPL Set ID 046465b7-ebad-4e57-838d-bbf8f7b7802d
Route
TOPICAL
Published
Effective Date 2023-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (73.4 mg) Octocrylene (50 mg) Octisalate
Inactive Ingredients
Water Aloe Vera Leaf Cetostearyl Alcohol Ceteth-20 Phosphate Dimethicone .alpha.-tocopherol Acetate Jojoba Oil Coconut Oil Caprylyl Glycol Glyceryl Laurate Myristyl Myristate Carbomer Homopolymer, Unspecified Type Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-02
Description

Avobenzone 3% Homosalate 7.34% Octocrylene 5% Octyl Salicylate 5%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 7.34% Octocrylene 5% Octyl Salicylate 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 generously 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 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.
Drug Facts

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

Avobenzone 3%

Homosalate 7.34%

Octocrylene 5%

Octyl Salicylate 5%

Inactive Ingredients

Water (Aqua/Eau), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), VP/Eicosene Copolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Dimethicone, Tocopheryl Acetate (Vitamin E Acetate), Simmondsia Chinensis (Jojoba) Seed Oil, Cocos Nucifera (Coconut) Oil, Caprylyl Glycol, Myristyl Laurate, Glyceryl Laurate, Myristyl Myristate, Fragrance (Parfum), Glyceryl Undecylenate, Carbomer, Aminomethyl Propanol.

When Using This Product
  • keep out of eyes.Rinse with water to remove
Stop Use and Ask A Doctor If
  • rash occurs
Package Labeling:53675 206 00

Package Labeling:53675 206 01

Keep Out of Reach of Children.
  • If 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.
Purpose

Sunscreen

Warnings

For external use only.

Directions
  • apply generously 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 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.
Drug Facts

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

Avobenzone 3%

Homosalate 7.34%

Octocrylene 5%

Octyl Salicylate 5%

Inactive Ingredients (Inactive ingredients)

Water (Aqua/Eau), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), VP/Eicosene Copolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Dimethicone, Tocopheryl Acetate (Vitamin E Acetate), Simmondsia Chinensis (Jojoba) Seed Oil, Cocos Nucifera (Coconut) Oil, Caprylyl Glycol, Myristyl Laurate, Glyceryl Laurate, Myristyl Myristate, Fragrance (Parfum), Glyceryl Undecylenate, Carbomer, Aminomethyl Propanol.

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
Package Labeling:53675 206 00 (Package Labeling:53675-206-00)

Package Labeling:53675 206 01 (Package Labeling:53675-206-01)

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:03.774704 · Updated: 2026-03-14T23:13:37.162375