drug facts

drug facts
SPL v3
SPL
SPL Set ID 82a6fbba-f0d4-475f-9ba7-615118eed70d
Route
topical
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (32 mg)
Inactive Ingredients
water cyclomethicone 5 alcohol phenyl trimethicone glycerin peg-14 dimethicone bis-peg/ppg-14/14 dimethicone dimethicone magnesium sulfate, unspecified form ethylhexyl hydroxystearate talc silicon dioxide disodium stearoyl glutamate poly(methyl methacrylate; 450000 mw) .alpha.-tocopherol acetate aluminum hydroxide magnesium stearate dipropylene glycol aluminum oxide butylated hydroxytoluene sodium citrate tocopherol isopropyl alcohol titanium dioxide ferric oxide red bismuth oxychloride

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2016-02-26 Until 2016-02-26

Purpose

Sunscreen

Description

Octinoxate 3.2%


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, cyclopentasiloxane, alcohol denat., phenyl trimethicone, glycerin, PEG-10 dimethicone, bis-PEG/PPG-14/14 dimethicone, dimethicone, magnesium sulfate, ethylhexyl hydroxystearate, talc, silica, PEG/PPG/polybutylene glycol-8/5/3 glycerin, disodium stearoyl glutamate, dimethicone/polyglycerin-3 crosspolymer, polymethyl methacrylate, tocopheryl acetate, aluminum hydroxide, magnesium stearate, silica silylate, dipropylene glycol, alumina, BHT, sodium citrate, tocopherol, isopropyl alcohol; may contain: titanium dioxide, iron oxides, bismuth oxychloride

Description

Octinoxate 3.2%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Octinoxate 3.2%

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, cyclopentasiloxane, alcohol denat., phenyl trimethicone, glycerin, PEG-10 dimethicone, bis-PEG/PPG-14/14 dimethicone, dimethicone, magnesium sulfate, ethylhexyl hydroxystearate, talc, silica, PEG/PPG/polybutylene glycol-8/5/3 glycerin, disodium stearoyl glutamate, dimethicone/polyglycerin-3 crosspolymer, polymethyl methacrylate, tocopheryl acetate, aluminum hydroxide, magnesium stearate, silica silylate, dipropylene glycol, alumina, BHT, sodium citrate, tocopherol, isopropyl 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 3.2%

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

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