Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 974b7e83-acc5-4b47-8bf7-78dc426f71cf
Route
TOPICAL
Published
Effective Date 2012-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (5 g) Oxybenzone (2 g)
Inactive Ingredients
Edetate Disodium Aloe Vera Leaf Water Sorbitan Sesquioleate Sorbitol Glyceryl Stearate Se Stearic Acid Isopropyl Myristate Trolamine Benzyl Alcohol Methylparaben Dimethicone Jojoba Oil Propylparaben .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-12-11
Description

Octinoxate   5.0% Oxybenzone 2.0%

Purpose

Sunscreen

Medication Information

Purpose
Sunscreen

Description

Octinoxate   5.0% Oxybenzone 2.0%

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • 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   5.0%

Oxybenzone 2.0%

Inactive Ingredients
Water, Sorbitan Sesquioleate, Sorbitol, Glyceryl Stearate SE, Stearic Acid, Isopropyl Myristate, Triethanolamine, VP/Eicosene  Copolymer, Benzyl Alcohol, Fragrance, Methylparaben, Dimethicone, Carbomer, Simmondsia Chinensis (Jojoba) Seed Oil, Propylparaben, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Disodium EDTA.

Principal Display Panel
CVS

pharmacy

SUNSCREEN

SPF 8

UVA/UVB Protection

VERY WATER

RESISTANT

LOTION

10 FL OZ (296 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 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   5.0%

Oxybenzone 2.0%

Inactive Ingredients (Inactive ingredients)
Water, Sorbitan Sesquioleate, Sorbitol, Glyceryl Stearate SE, Stearic Acid, Isopropyl Myristate, Triethanolamine, VP/Eicosene  Copolymer, Benzyl Alcohol, Fragrance, Methylparaben, Dimethicone, Carbomer, Simmondsia Chinensis (Jojoba) Seed Oil, Propylparaben, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Disodium EDTA.

Principal Display Panel
CVS

pharmacy

SUNSCREEN

SPF 8

UVA/UVB Protection

VERY WATER

RESISTANT

LOTION

10 FL OZ (296 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: 2026-02-15T11:55:34.781733 · Updated: 2026-03-14T22:53:23.299879