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

Purpose

Sunscreen

Description

Octinoxate 6.7% Titanium dioxide 3.6%


Medication Information

Warnings

For external use only

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

Purpose

Sunscreen

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

Other Information

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

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

Description

Octinoxate 6.7% Titanium dioxide 3.6%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Octinoxate 6.7%

Titanium dioxide 3.6%

Flammable Until Dry.

Do not use near fire, flame or heat.

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

Warnings

For external use only

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

Purpose

Sunscreen

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

Other Information (Other information)

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

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

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

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.

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)