Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 6ae5cd63-0869-4301-bcda-152d38426bb5
Route
TOPICAL
Published
Effective Date 2012-11-13
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 Isopropyl Myristate Trolamine Benzyl Alcohol Imidurea Methylparaben Dimethicone Jojoba Oil Propylparaben Tocopherol Aloe Vera Leaf Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-11-13
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
  • shake well
  • apply generously before sun exposure and as needed
  • Children under 6 months of age:ask a doctor
  • reapplying frequently after towel drying, swimming or perspiring.

Active Ingredients

Octinoxate 7.5%

Oxybenzone 4.5%

Inactive Ingredients

Water, Stearic Acid, Sorbitol, Sorbitan Oleate, Glyceryl Stearate SE, Hydrogenated Vegetable oil Isopropyl Myristate, Triethanolamine,VP/Eicosene Copolymer, Benzyl Alcohol, Imadazolidinyl Urea, Methylparaben, Dimethicone,Carbomer, Fragrance,Simmondsia Chinensis(Jojoba) Seed Oil, Propylparaben, Tocopherol, Aloe Barbadensis Leaf Juice, Disodium EDTA.

Principal Display Panel

UNIQUELY NY DRTM SINCE 1960

SUNSCREEN

15

SPF

moisturizing lotion

UVA/UVB Protection

Very water resistant

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.
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
  • shake well
  • apply generously before sun exposure and as needed
  • Children under 6 months of age:ask a doctor
  • reapplying frequently after towel drying, swimming or perspiring.

Active Ingredients

Octinoxate 7.5%

Oxybenzone 4.5%

Inactive Ingredients

Water, Stearic Acid, Sorbitol, Sorbitan Oleate, Glyceryl Stearate SE, Hydrogenated Vegetable oil Isopropyl Myristate, Triethanolamine,VP/Eicosene Copolymer, Benzyl Alcohol, Imadazolidinyl Urea, Methylparaben, Dimethicone,Carbomer, Fragrance,Simmondsia Chinensis(Jojoba) Seed Oil, Propylparaben, Tocopherol, Aloe Barbadensis Leaf Juice, Disodium EDTA.

Principal Display Panel

UNIQUELY NY DRTM SINCE 1960

SUNSCREEN

15

SPF

moisturizing lotion

UVA/UVB Protection

Very water resistant

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.
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

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Source: dailymed · Ingested: 2026-02-15T11:55:33.102798 · Updated: 2026-03-14T22:53:19.872567