SPL v1
SPL
SPL Set ID 258e8f05-295e-8e32-e063-6294a90a7548
Route
TOPICAL
Published
Effective Date 2021-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (30 mg)
Inactive Ingredients
Butylene Glycol Hexylene Glycol Glycerin (4-nitrophenyl)urea Triethoxycaprylylsilane Cetearyl Ethylhexanoate Sodium Hyaluronate Laureth-30 Trehalose Bht Chlorphenesin Sodium Dehydroacetate Sodium Pca Laureth-7 Talc Tribehenin Iron Oxides Trihydroxystearin Disteardimonium Hectorite Magnesium Sulfate Bis-peg/ppg-14/14 Dimethicone Caprylyl Glycol Triacetin Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Phenoxyethanol Propylene Carbonate Xanthan Gum Disodium Deceth-6 Sulfosuccinate Cyclopentasiloxane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-01
Description

Octinoxate 3.0%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Octinoxate 3.0%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures

(see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

Skin Cancer/Skin Aging Alert; ;Spending time inthesunincreasesyourriskofskincancerand earlyskinaging.Thisproducthasbeenshown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

Directions
  • apply liberally 15 minutes before sun exposure
  • useawaterresistantsunscreenif swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • 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 witha Broad SpectrumSPF valueof 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.
Do Not Use
  • on damaged or broken skin.
Package Label

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

Octinoxate 3.0%

Inactive Ingredients

CYCLOPENTASILOXANE, AQUA/WATER/EAU, TALC, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, ACRYLATES CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, CETEARYL ETHYLHEXANOATE, DIMETHICONE/ VINYL DIMETHICONE CROSSPOLYMER, MAGNESIUM SULFATE, BIS-PEG/PPG-14/ 14 DIMETHICONE, AMMONIUM

ACRYLATES COPOLYMER, TRIBEHENIN, DISTEARDIMONIUM HECTORITE, LAURETH-7, LECITHIN, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, TRIHYDROXYSTEARIN, CHLORPHENESIN, PROPYLENE CARBONATE, ALCOHOL DENAT., DIMETHICONOL, XANTHAN GUM, GLYCERIN, DISODIUM EDTA, TOCOPHERYL ACETATE, DISODIUM DECETH-6 SULFOSUCCINATE, LAURETH-30, SODIUM PCA, UREA, SODIUM DEHYDROACETATE, TREHALOSE, HEXYLENE GLYCOL, POLYQUATERNIUM-51, BHT, CAPRYLYL GLYCOL, TRIACETIN, SODIUM HYALURONATE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, [MAY CONTAIN/PEUT CONTENIR/+/-: IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891)].

Questions Or Comments?

Call 1-800-426-8374

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask Doctor If
  • rash occurs.
Keep Out of Reach of Children.

If swollowed, 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 aging caused by the sun.

Purpose

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert; ;Spending time inthesunincreasesyourriskofskincancerand earlyskinaging.Thisproducthasbeenshown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

Directions
  • apply liberally 15 minutes before sun exposure
  • useawaterresistantsunscreenif swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • 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 witha Broad SpectrumSPF valueof 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.
Do Not Use (Do not use)
  • on damaged or broken skin.
Package Label

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

Octinoxate 3.0%

Inactive Ingredients (Inactive ingredients)

CYCLOPENTASILOXANE, AQUA/WATER/EAU, TALC, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, ACRYLATES CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, CETEARYL ETHYLHEXANOATE, DIMETHICONE/ VINYL DIMETHICONE CROSSPOLYMER, MAGNESIUM SULFATE, BIS-PEG/PPG-14/ 14 DIMETHICONE, AMMONIUM

ACRYLATES COPOLYMER, TRIBEHENIN, DISTEARDIMONIUM HECTORITE, LAURETH-7, LECITHIN, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, TRIHYDROXYSTEARIN, CHLORPHENESIN, PROPYLENE CARBONATE, ALCOHOL DENAT., DIMETHICONOL, XANTHAN GUM, GLYCERIN, DISODIUM EDTA, TOCOPHERYL ACETATE, DISODIUM DECETH-6 SULFOSUCCINATE, LAURETH-30, SODIUM PCA, UREA, SODIUM DEHYDROACETATE, TREHALOSE, HEXYLENE GLYCOL, POLYQUATERNIUM-51, BHT, CAPRYLYL GLYCOL, TRIACETIN, SODIUM HYALURONATE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, [MAY CONTAIN/PEUT CONTENIR/+/-: IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891)].

Questions Or Comments? (Questions or comments?)

Call 1-800-426-8374

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • rash occurs.
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.148697 · Updated: 2026-03-14T23:05:17.700396