drug facts

drug facts
SPL v15
SPL
SPL Set ID 9598949a-0dd6-4932-9dc8-354f9e10b601
Route
topical
Published
Effective Date 2023-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (67 mg) titanium dioxide (18 mg)
Inactive Ingredients
water dimethicone isododecane alcohol trimethylsiloxysilicate (m/q 0.8-1.0) butylene glycol peg-10 dimethicone (600 cst) magnesium potassium aluminosilicate fluoride phenyl trimethicone glycerin perlite isopropyl lauroyl sarcosinate diisopropyl sebacate disteardimonium hectorite hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer bis-peg/ppg-14/14 dimethicone magnesium sulfate, unspecified form phenoxyethanol disodium stearoyl glutamate aluminum hydroxide dipentaerythrityl tetrahydroxystearate/tetraisostearate hydrogen dimethicone (13 cst) magnesium silicate silicon dioxide linalool, (+/-)- limonene, (+)- butylated hydroxytoluene bergamot oil stannic oxide .beta.-citronellol, (r)- benzyl alcohol ferric oxide red bismuth oxychloride

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-02-01

Purpose

Sunscreen

Description

Octinoxate 6.7% Titanium dioxide 1.8%


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 before use

● apply generously 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, synthetic fluorphlogopite, phenyl trimethicone, glycerin, perlite, isopropyl lauroyl sarcosinate, diisopropyl sebacate, disteardimonium hectorite, HDI/trimethylol hexyllactone crosspolymer, bis-PEG/PPG-14/14 dimethicone, magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, aluminum hydroxide, dipentaerythrityl tetrahydroxystearate/tetraisostearate, hydrogen dimethicone, fragrance, silica silylate, magnesium silicate, silica, linalool, limonene, BHT, citrus aurantium bergamia (bergamot) fruit oil, tin oxide, citronellol, benzyl alcohol; may contain: titanium dioxide, iron oxides, bismuth oxychloride

Description

Octinoxate 6.7% Titanium dioxide 1.8%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Octinoxate 6.7%

Titanium dioxide 1.8%

Flammable Until Dry.

Do not use near fire, flame or heat.

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 before use

● apply generously 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, synthetic fluorphlogopite, phenyl trimethicone, glycerin, perlite, isopropyl lauroyl sarcosinate, diisopropyl sebacate, disteardimonium hectorite, HDI/trimethylol hexyllactone crosspolymer, bis-PEG/PPG-14/14 dimethicone, magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, aluminum hydroxide, dipentaerythrityl tetrahydroxystearate/tetraisostearate, hydrogen dimethicone, fragrance, silica silylate, magnesium silicate, silica, linalool, limonene, BHT, citrus aurantium bergamia (bergamot) fruit oil, tin oxide, citronellol, benzyl alcohol; may contain: titanium dioxide, iron oxides, bismuth oxychloride

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 1.8%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flame or heat.

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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