drug facts

drug facts
SPL v1
SPL
SPL Set ID f6457973-3718-44cd-a764-de0b089d4eee
Route
topical
Published
Effective Date 2024-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (67 mg) titanium dioxide (46 mg)
Inactive Ingredients
water dimethicone isododecane alcohol butylene glycol perlite nylon-12 isopropyl lauroyl sarcosinate diisopropyl sebacate hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer disteardimonium hectorite bis-peg/ppg-14/14 dimethicone magnesium sulfate, unspecified form aluminum hydroxide phenoxyethanol disodium stearoyl glutamate powdered cellulose dipentaerythrityl tetrahydroxystearate/tetraisostearate ascorbyl glucoside calcium aluminum borosilicate tocopherol silicon dioxide .alpha.-hexylcinnamaldehyde benzyl salicylate butylated hydroxytoluene linalool, (+/-)- isomethyl-.alpha.-ionone benzyl alcohol .beta.-citronellol, (r)- ferric oxide red bismuth oxychloride mica

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-09-01

Purpose

Sunscreen

Description

Octinoxate 6.7% Titanium dioxide 4.6%


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 beore using
  • 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 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, HDI/trimethylol hexyllactone crosspolymer,  disteardimonium hectorite, BIS -PEG/PPG-14/14 dimethicone,  magnesium sulfate,  aluminum hydroxide,  phenoxyethanol,  disodium stearoyl glutamate,  hydrogen dimethicone,  cellulose,  dipentaerythrityl tetrahydroxystearate/tetraisostearate,  ascorbyl glucoside,  silica silylate,  fragrance,  calcium aluminum borosilicate,  tocopherol,  silica,  hexyl cinnamal,  benzyl salicylate, BHT,  linalool,  alpha-isomethyl ionone,  benzyl alcohol,  citronellol; may contain:  titanium dioxide,  iron oxides,  bismuth oxychloride,  mica

Description

Octinoxate 6.7% Titanium dioxide 4.6%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Octinoxate 6.7%

Titanium dioxide 4.6%

Flammable Until Dry.

Do not use near fire, flames 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 beore using
  • 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 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, HDI/trimethylol hexyllactone crosspolymer,  disteardimonium hectorite, BIS -PEG/PPG-14/14 dimethicone,  magnesium sulfate,  aluminum hydroxide,  phenoxyethanol,  disodium stearoyl glutamate,  hydrogen dimethicone,  cellulose,  dipentaerythrityl tetrahydroxystearate/tetraisostearate,  ascorbyl glucoside,  silica silylate,  fragrance,  calcium aluminum borosilicate,  tocopherol,  silica,  hexyl cinnamal,  benzyl salicylate, BHT,  linalool,  alpha-isomethyl ionone,  benzyl alcohol,  citronellol; may contain:  titanium dioxide,  iron oxides,  bismuth oxychloride,  mica

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 4.6%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flames 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.


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Raw Label Data

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