Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 12ec5a93-8c24-4ac9-94df-910dd8137e00
Route
TOPICAL
Published
Effective Date 2024-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg)
Inactive Ingredients
Water Glycerin Isotridecyl Isononanoate Peg-9 Polydimethylsiloxyethyl Dimethicone Disteardimonium Hectorite Phenoxyethanol Disodium Stearoyl Glutamate Chlorphenesin Methylparaben Lycium Barbarum Fruit Potassium Sorbate Ethylparaben Tocopherol Ascorbyl Palmitate Panthenol Aluminum Hydroxide Citric Acid Monohydrate Butylated Hydroxytoluene Sodium Pyrrolidone Carboxylate Propylene Glycol Urea Edetic Acid Stannic Oxide Ethylhexylglycerin Trehalose Hyaluronate Sodium Edetate Trisodium Benzoic Acid Titanium Dioxide Mica Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-14
Description

Octinoxate 7.5%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.5%

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:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscren if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases our 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

Active Ingredient

Octinoxate 7.5%

Other Information
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients

cyclopentasiloxane, water, dimethicone crosspolymer, glycerin, isotridecyl isononanoate, PEG-9 polydimethylsiloxyethyl dimethicone, disteardimonium hectorite, phenoxyethanol, PEG-10 dimethicone, hydrolyzed wheat protein/pvp crosspolymer, disodium stearoyl glutamate, chlorphenesin, methylparaben, lycium barbarum fruit extract, silica silylate, potassium sorbate, ethylparaben, tocopherol, ascorbyl palmitate, panthenol, aluminum hydroxide, citric acid, BHT, sodium PCA, propylene glycol, urea, EDTA, tin oxide, ethylhexylglycerin, trehalose, polyquaternium-51, soluble collagen, sodium hyaluronate, trisodium EDTA, benzoic acid; may contain: titanium dioxide, mica, iron oxides

Questions Or Comments?

1-800-322-2036

Monday - Friday (9 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:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscren if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases our 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

Active Ingredient (Active ingredient)

Octinoxate 7.5%

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

cyclopentasiloxane, water, dimethicone crosspolymer, glycerin, isotridecyl isononanoate, PEG-9 polydimethylsiloxyethyl dimethicone, disteardimonium hectorite, phenoxyethanol, PEG-10 dimethicone, hydrolyzed wheat protein/pvp crosspolymer, disodium stearoyl glutamate, chlorphenesin, methylparaben, lycium barbarum fruit extract, silica silylate, potassium sorbate, ethylparaben, tocopherol, ascorbyl palmitate, panthenol, aluminum hydroxide, citric acid, BHT, sodium PCA, propylene glycol, urea, EDTA, tin oxide, ethylhexylglycerin, trehalose, polyquaternium-51, soluble collagen, sodium hyaluronate, trisodium EDTA, benzoic acid; may contain: titanium dioxide, mica, iron oxides

Questions Or Comments? (Questions or comments?)

1-800-322-2036

Monday - Friday (9 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:13.058069 · Updated: 2026-03-14T23:03:10.704753