broad spectrum spf30 very water resistant (80 min) sunscreen

broad spectrum spf30 very water resistant (80 min) sunscreen
SPL v1
SPL
SPL Set ID bcd03000-f8eb-4702-987d-03ae5ee70a68
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 (100 mg) octisalate (50 mg)
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
Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 7.34% Octocrylene 5% Octyl Salicylate 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 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.
Other Information
  • protect the product in this container from excessive heat and direct sun.
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.

Description

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

Do Not Use
  • on damaged or broken skin.
Drug Facts

Active Ingredients

Avobenzone 3%

Homosalate 7.34%

Octocrylene 5%

Octyl Salicylate 5%

Package Labeling:30ml

Package Labeling:59ml

Package Labeling:177ml

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

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

Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 7.34%

Octocrylene 5%

Octyl Salicylate 5%

Package Labeling:30ml

Package Labeling:59ml

Package Labeling:177ml

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:23.634533 · Updated: 2026-03-14T23:01:53.224533