drug facts

drug facts
SPL v10
SPL
SPL Set ID df62e1c2-ce72-4ded-8985-156dce9ff41d
Route
topical
Published
Effective Date 2024-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (32 mg) octocrylene (60 mg)
Inactive Ingredients
water cyclomethicone 5 isododecane isononyl isononanoate glycerin cetyl peg/ppg-10/1 dimethicone (hlb 1.5) dimethicone magnesium sulfate, unspecified form polyglyceryl-4 isostearate disodium stearoyl glutamate disteardimonium hectorite phenoxyethanol polybutene (1400 mw) methylparaben alcohol chlorphenesin butylparaben aluminum hydroxide hyaluronate sodium isobutane dipropylene glycol sodium citrate tocopherol pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) titanium dioxide ferric oxide red

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-01-01

Purpose

Sunscreen

Description

Octisalate 3.2% Octocrylene 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:

● 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, cyclopentasiloxane, isododecane, isononyl isononanoate, glycerin, cetyl PEG/PPG-10/1 dimethicone, dimethicone, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, disteardimonium hectorite, phenoxyethanol, polybutene, methylparaben, alcohol denat., chlorphenesin, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, butylparaben, aluminum hydroxide, sodium hydroxide, isobutane, dipropylene glycol, sodium citrate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides

Description

Octisalate 3.2% Octocrylene 6%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Octisalate 3.2%

Octocrylene 6%

Questions Or Comments?

1-877-900-6700

Monday - Friday (9 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:

● 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, cyclopentasiloxane, isododecane, isononyl isononanoate, glycerin, cetyl PEG/PPG-10/1 dimethicone, dimethicone, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, disteardimonium hectorite, phenoxyethanol, polybutene, methylparaben, alcohol denat., chlorphenesin, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, butylparaben, aluminum hydroxide, sodium hydroxide, isobutane, dipropylene glycol, sodium citrate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Octisalate 3.2%

Octocrylene 6%

Questions Or Comments? (Questions or comments?)

1-877-900-6700

Monday - Friday (9 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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