drug facts

drug facts
SPL v6
SPL
SPL Set ID 965be0b9-2cfb-4325-8feb-d311a6ef5969
Route
topical
Published
Effective Date 2024-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (30 mg)
Inactive Ingredients
dimethicone cyclomethicone 6 isododecane alcohol vinyl dimethicone/methicone silsesquioxane crosspolymer phenyl trimethicone peg-10 dimethicone (600 cst) disteardimonium hectorite silicon dioxide limonene, (+)- benzyl salicylate linalool, (+/-)- benzyl alcohol propylene carbonate medium-chain triglycerides disodium stearoyl glutamate water citrus aurantium flower oil butylphenyl methylpropional aluminum hydroxide .alpha.-hexylcinnamaldehyde mica ferric oxide red titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2015-01-01 Until 2026-03-15

Purpose

Sunscreen

Description

Octinoxate 3%


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

dimethicone, cyclohexasiloxane, isododecane, alcohol denat., vinyl dimethicone/methicone silsesquioxane crosspolymer, phenyl trimethicone, acrylates/polytrimethylsiloxymethacrylate copolymer, PEG-10 dimethicone, disteardimonium hectorite, fragrance, silica, nelumbium speciosum flower extract, limonene, benzyl salicylate, linalool, benzyl alcohol, propylene carbonate, caprylic/capric triglyceride, disodium stearoyl glutamate, water, citrus aurantium amara (bitter orange) flower oil, butylphenyl methylpropional, aluminum hydroxide, hexyl cinnamal; mayt contain: mica, iron oxides, titanium dioxide

Description

Octinoxate 3%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredient

Octinoxate 3%

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 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)

dimethicone, cyclohexasiloxane, isododecane, alcohol denat., vinyl dimethicone/methicone silsesquioxane crosspolymer, phenyl trimethicone, acrylates/polytrimethylsiloxymethacrylate copolymer, PEG-10 dimethicone, disteardimonium hectorite, fragrance, silica, nelumbium speciosum flower extract, limonene, benzyl salicylate, linalool, benzyl alcohol, propylene carbonate, caprylic/capric triglyceride, disodium stearoyl glutamate, water, citrus aurantium amara (bitter orange) flower oil, butylphenyl methylpropional, aluminum hydroxide, hexyl cinnamal; mayt contain: mica, iron oxides, titanium dioxide

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Octinoxate 3%

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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