Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 90660f78-7f88-46b2-8cf9-0a339331e5b5
Route
TOPICAL
Published
Effective Date 2012-11-15
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 Sorbitan Monostearate Sorbitol Glyceryl Stearate Se Hydrogenated Soybean Oil Isopropyl Myristate Trolamine Benzyl Alcohol Dimethicone Jojoba Oil Tocopherol Edetate Disodium Aloe Vera Leaf Imidurea Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-11-15
Description

Octinoxate 7.5% Oxybenzone 4.5%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.5% Oxybenzone 4.5%

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

Warnings

For external use only

Directions
  • apply generously 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 fabrics

  • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cance, and other harmful effects of the sun.

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

exchange

select

X

SUNSCREEN

Lotion

SPF

15

UVA/UVB Protection

Very Water Resistant

4 FL. OZ. (118 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.

Keep Out of the Reach of Children.

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

Structured Label Content

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

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply generously 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 fabrics

  • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cance, and other harmful effects of the sun.

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

exchange

select

X

SUNSCREEN

Lotion

SPF

15

UVA/UVB Protection

Very Water Resistant

4 FL. OZ. (118 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.

Keep Out of the Reach of Children. (Keep Out of the 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:33.167008 · Updated: 2026-03-14T22:53:19.872567