Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 82a6fbba-f0d4-475f-9ba7-615118eed70d
Route
TOPICAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (32 mg)
Inactive Ingredients
Water Cyclomethicone 5 Alcohol Phenyl Trimethicone Glycerin Peg-14 Dimethicone Bis-peg/ppg-14/14 Dimethicone Dimethicone Magnesium Sulfate, Unspecified Form Ethylhexyl Hydroxystearate Talc Silicon Dioxide Disodium Stearoyl Glutamate Poly(methyl Methacrylate; 450000 Mw) .alpha.-tocopherol Acetate Aluminum Hydroxide Magnesium Stearate Dipropylene Glycol Aluminum Oxide Butylated Hydroxytoluene Sodium Citrate Tocopherol Isopropyl Alcohol Titanium Dioxide Ferric Oxide Red Bismuth Oxychloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-02-26 Until 2016-02-26
Description

Octinoxate 3.2%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Octinoxate 3.2%

Uses

- helps prevent sunburn

- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Section 51945-4

Warnings

For external use only

Directions

For sunscreen use:

● shake well

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

● limit time in the sun, especially from 10 a.m. – 2 p.m.

● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

protect the product in this container from excessive heat and direct sun

Active Ingredients

Octinoxate 3.2%

Flammable Until Dry.

Do not use near fire, flame or heat.

Inactive Ingredients

water, cyclopentasiloxane, alcohol denat., phenyl trimethicone, glycerin, PEG-10 dimethicone, bis-PEG/PPG-14/14 dimethicone, dimethicone, magnesium sulfate, ethylhexyl hydroxystearate, talc, silica, PEG/PPG/polybutylene glycol-8/5/3 glycerin, disodium stearoyl glutamate, dimethicone/polyglycerin-3 crosspolymer, polymethyl methacrylate, tocopheryl acetate, aluminum hydroxide, magnesium stearate, silica silylate, dipropylene glycol, alumina, BHT, sodium citrate, tocopherol, isopropyl alcohol; may contain: titanium dioxide, iron oxides, bismuth oxychloride

Questions Or Comments?

1-800-322-2036

Monday - Friday

(10 a.m. - 5 p.m. EST)

When Using This Product

 keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

rash occurs

Keep Out of Reach of Children.

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

Structured Label Content

Uses

- helps prevent sunburn

- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

For sunscreen use:

● shake well

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

● limit time in the sun, especially from 10 a.m. – 2 p.m.

● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

protect the product in this container from excessive heat and direct sun

Active Ingredients (Active ingredients)

Octinoxate 3.2%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flame or heat.

Inactive Ingredients (Inactive ingredients)

water, cyclopentasiloxane, alcohol denat., phenyl trimethicone, glycerin, PEG-10 dimethicone, bis-PEG/PPG-14/14 dimethicone, dimethicone, magnesium sulfate, ethylhexyl hydroxystearate, talc, silica, PEG/PPG/polybutylene glycol-8/5/3 glycerin, disodium stearoyl glutamate, dimethicone/polyglycerin-3 crosspolymer, polymethyl methacrylate, tocopheryl acetate, aluminum hydroxide, magnesium stearate, silica silylate, dipropylene glycol, alumina, BHT, sodium citrate, tocopherol, isopropyl alcohol; may contain: titanium dioxide, iron oxides, bismuth oxychloride

Questions Or Comments? (Questions or comments?)

1-800-322-2036

Monday - Friday

(10 a.m. - 5 p.m. EST)

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 occurs

Keep Out of Reach of Children. (Keep out of 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: 2026-02-15T12:02:36.559162 · Updated: 2026-03-14T23:02:16.200124