Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 917f6775-8f48-4b7e-9f67-253bc0c6d59e
Route
TOPICAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (67 mg) Titanium Dioxide (36 mg)
Inactive Ingredients
Water Dimethicone Isododecane Alcohol Trimethylsiloxysilicate (m/q 0.6-0.8) Butylene Glycol Peg-10 Dimethicone (600 Cst) Perlite Magnesium Potassium Aluminosilicate Fluoride Nylon-12 Isopropyl Lauroyl Sarcosinate Diisopropyl Sebacate Disteardimonium Hectorite Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Bis-peg/ppg-14/14 Dimethicone Magnesium Sulfate, Unspecified Form Aluminum Hydroxide Phenoxyethanol Disodium Stearoyl Glutamate Hydrogen Dimethicone (13 Cst) Dipentaerythrityl Tetrahydroxystearate/tetraisostearate Tocopherol .alpha.-hexylcinnamaldehyde Silicon Dioxide Isobutane Benzyl Salicylate Linalool, (+/-)- Isomethyl-.alpha.-ionone Benzyl Alcohol Butylated Hydroxytoluene .beta.-citronellol, (r)- Ferric Oxide Red Ferric Ammonium Ferrocyanide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-01

Description

Octinoxate 6.7% Titanium dioxide 3.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 6.7% Titanium dioxide 3.6%

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 6.7%

Titanium dioxide 3.6%

Flammable Until Dry.

Do not use near fire, flame or heat.

Inactive Ingredients

water, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, perlite, synthetic fluorphlogopite, nylon-12, isopropyl lauroyl sarcosinate, diisopropyl sebacate, disteardimonium hectorite, HDI/trimethylol hexyllactone crosspolymer, bis-PEG/PPG-14/14 dimethicone, magnesium sulfate, aluminum hydroxide, phenoxyethanol, disodium stearoyl glutamate, hydrogen dimethicone, dipentaerythrityl tetrahydroxystearate/tetraisostearate, fragrance, silica silylate, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, tocopherol, hexyl cinnamal, silica, isobutane, benzyl salicylate, linalool, alpha-isomethyl ionone, benzyl alcohol, BHT, citronellol, may contain: titanium dioxide, iron oxides, ferric ammonium ferrocyanide

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 6.7%

Titanium dioxide 3.6%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flame or heat.

Inactive Ingredients (Inactive ingredients)

water, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, perlite, synthetic fluorphlogopite, nylon-12, isopropyl lauroyl sarcosinate, diisopropyl sebacate, disteardimonium hectorite, HDI/trimethylol hexyllactone crosspolymer, bis-PEG/PPG-14/14 dimethicone, magnesium sulfate, aluminum hydroxide, phenoxyethanol, disodium stearoyl glutamate, hydrogen dimethicone, dipentaerythrityl tetrahydroxystearate/tetraisostearate, fragrance, silica silylate, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, tocopherol, hexyl cinnamal, silica, isobutane, benzyl salicylate, linalool, alpha-isomethyl ionone, benzyl alcohol, BHT, citronellol, may contain: titanium dioxide, iron oxides, ferric ammonium ferrocyanide

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

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