drug facts

drug facts
SPL v5
SPL
SPL Set ID e6c77821-a5c7-42f6-ac31-7dc7024bf22a
Route
topical
Published
Effective Date 2024-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (67 mg) titanium dioxide (11 mg)
Inactive Ingredients
water dimethicone isododecane alcohol trimethylsiloxysilicate (m/q 0.6-0.8) butylene glycol magnesium potassium aluminosilicate fluoride peg-10 dimethicone (600 cst) perlite disteardimonium hectorite nylon-12 hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer isopropyl lauroyl sarcosinate diisopropyl sebacate bis-peg/ppg-14/14 dimethicone magnesium sulfate, unspecified form phenoxyethanol disodium stearoyl glutamate dipentaerythrityl tetrahydroxystearate/tetraisostearate glycerin tocopherol medium-chain triglycerides hydrogen dimethicone (13 cst) silicon dioxide butylated hydroxytoluene jasminum officinale flower benzyl alcohol hyaluronate sodium phenylethyl alcohol linalool, (+/-)- carrageenan lemon peel ferric oxide red

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-07-25 Until 2026-06-28

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 before use
  • 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, synthetic fluorphlogopite, perlite, disteardimonium hectorite, nylon-12, HDI/trimethylol hexyllactone crosspolymer, aluminum hydroxide, isopropyl lauroyl sarcosinate, diisopropyl sebacate, bis-PEG/PPG-14/14 dimethicone,magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, aluminum hydroxide, dipentaerythrityl tetrahydroxystearate/tetraisostearate, silica silylate, glycerin, tocopherol, caprylic/capric triglyceride, hydrogen dimethicone, silica, BHT, jasminum officinale (jasmine) flower extract, benzyl alcohol, sodium hyaluronate, phenethyl alcohol, linalool, sodium carrageenan, citrus limon (lemon) peel extract, jania rubens extract, fragrance; may contain: iron oxides, titanium dioxide

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.

Avoid fire, flame and heat during application.

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 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, synthetic fluorphlogopite, perlite, disteardimonium hectorite, nylon-12, HDI/trimethylol hexyllactone crosspolymer, aluminum hydroxide, isopropyl lauroyl sarcosinate, diisopropyl sebacate, bis-PEG/PPG-14/14 dimethicone,magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, aluminum hydroxide, dipentaerythrityl tetrahydroxystearate/tetraisostearate, silica silylate, glycerin, tocopherol, caprylic/capric triglyceride, hydrogen dimethicone, silica, BHT, jasminum officinale (jasmine) flower extract, benzyl alcohol, sodium hyaluronate, phenethyl alcohol, linalool, sodium carrageenan, citrus limon (lemon) peel extract, jania rubens extract, fragrance; may contain: iron oxides, titanium dioxide

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.)

Avoid fire, flame and heat during application.

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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