Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2794cba1-2f6c-4fc0-86c1-54bd7413338e
Route
TOPICAL
Published
Effective Date 2012-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Oxybenzone (4.5 g)
Inactive Ingredients
Water Stearic Acid Sorbitol Sorbitan Monooleate Glyceryl Stearate Se Hydrogenated Soybean Oil Isopropyl Myristate Trolamine Benzyl Alcohol Imidurea Methylparaben Dimethicone Jojoba Oil Propylparaben Tocopherol Edetate Disodium Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-11-16
Description

Octinoxate 7.5% Oxybenzone 4.5%

Purpose

Sunscreen

Medication Information

Purpose
Sunscreen

Description

Octinoxate 7.5% Oxybenzone 4.5%

Uses
  • Sun Protection Factor 15
  • helps prevent sunburn

  • retains SPF after 80 minutes of activity in water

Section 50565-1
Keep out of the reach 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

Active Ingredients
Octinoxate 7.5%

Oxybenzone 4.5%

Inactive Ingredients
Water, Stearic Acid, Sorbitan Oleate, Sorbitol, Glyceryl Stearate SE, Hydrogenated Soybean Oil, Isopropyl Myristate, Triethanolamine, VP/Eicosene Copolymer, Benzyl Alcohol, Dimethicone, Carbomer, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice, Imidazolidinyl Urea, Methylparaben, Propylparaben, Fragrance.
Principal Display Panel
select brand

the lower price name brand

SUNSCREEN

LOTION

15 SPF

Very Water Resistant

UVA/UVB Protection

Vitamin E and Aloe

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
  • Sun Protection Factor 15
  • helps prevent sunburn

  • retains SPF after 80 minutes of activity in water

Section 50565-1 (50565-1)
Keep out of the reach 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

Active Ingredients (Active ingredients)
Octinoxate 7.5%

Oxybenzone 4.5%

Inactive Ingredients (Inactive ingredients)
Water, Stearic Acid, Sorbitan Oleate, Sorbitol, Glyceryl Stearate SE, Hydrogenated Soybean Oil, Isopropyl Myristate, Triethanolamine, VP/Eicosene Copolymer, Benzyl Alcohol, Dimethicone, Carbomer, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice, Imidazolidinyl Urea, Methylparaben, Propylparaben, Fragrance.
Principal Display Panel
select brand

the lower price name brand

SUNSCREEN

LOTION

15 SPF

Very Water Resistant

UVA/UVB Protection

Vitamin E and Aloe

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: 2026-02-15T11:55:33.232751 · Updated: 2026-03-14T22:53:19.872567