Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a5f27b24-e9ac-43f5-ad66-3f9e42d8cf70
Route
TOPICAL
Published
Effective Date 2012-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (13 g) Octisalate (5 g) Octocrylene (7 g) Oxybenzone (4 g)
Inactive Ingredients
Water Sorbitol Stearic Acid Trolamine Aluminum Starch Octenylsuccinate Benzyl Alcohol Sorbitan Isostearate Dimethicone Methylparaben Tocopherol Propylparaben Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-11-20
Description

Avobenzone 3.0% Homosalate 13.0% Octisalate    5.0% Octocrylene 7.0% Oxybenzone 4.0%

Purpose

Sunscreen

Medication Information

Purpose
Sunscreen

Description

Avobenzone 3.0% Homosalate 13.0% Octisalate    5.0% Octocrylene 7.0% Oxybenzone 4.0%

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water

Section 50565-1
Keep out of each of children.If swallowed get medical help or contact a Poison Control Center right away.

Warnings
For external use only
Directions
  • shake well

  • apply generously and evenly before sun exposure and as needed
  • children under 6 months of age: ask a doctor
  • reapply frequently and after towel drying,swimming or perspiring

Other Information
  • may stain some materials

Active Ingredients
Avobenzone 3.0%

Homosalate 13.0%

Octisalate    5.0%

Octocrylene 7.0%

Oxybenzone 4.0%

Inactive Ingredients
Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.

Principal Display Panel
select brand

the lower price name brand

Baby

SUNSCREEN

50 SPF

Very Water Resistant

UVB/UVA Protection

PEDIATRICIAN TESTED

8 FL OZ (237 mL)

When Using This Product
  • keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts

Structured Label Content

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water

Section 50565-1 (50565-1)
Keep out of each of children.If swallowed get medical help or contact a Poison Control Center right away.

Purpose
Sunscreen

Warnings
For external use only
Directions
  • shake well

  • apply generously and evenly before sun exposure and as needed
  • children under 6 months of age: ask a doctor
  • reapply frequently and after towel drying,swimming or perspiring

Other Information (Other information)
  • may stain some materials

Active Ingredients (Active ingredients)
Avobenzone 3.0%

Homosalate 13.0%

Octisalate    5.0%

Octocrylene 7.0%

Oxybenzone 4.0%

Inactive Ingredients (Inactive ingredients)
Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.

Principal Display Panel
select brand

the lower price name brand

Baby

SUNSCREEN

50 SPF

Very Water Resistant

UVB/UVA Protection

PEDIATRICIAN TESTED

8 FL OZ (237 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 or irritation develops and lasts

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:33.633387 · Updated: 2026-03-14T22:53:19.872567