drug facts

drug facts
SPL v1
SPL
SPL Set ID b3a37055-b58f-4c42-963b-01c1136f692d
Route
topical
Published
Effective Date 2025-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (70 mg)
Inactive Ingredients
water cyclopentasiloxane dimethicone glycerin isotridecyl isononanoate peg-9 polydimethylsiloxyethyl dimethicone disteardimonium hectorite dimethicone/polyglycerin-3 crosspolymer sodium chloride phenoxyethanol peg-10 dimethicone (600 cst) methylparaben disodium stearoyl glutamate chlorphenesin trisodium ethylenediamine disuccinate tocopherol ascorbyl palmitate aluminum hydroxide dipropylene glycol bht alpha-isomethyl ionone titanium dioxide ferrosoferric oxide ferric oxide red ferric oxide yellow

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-01-14

Purpose

Sunscreen

Description

Octinoxate 7%


Medication Information

Warnings

For external use only

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

● children under 6 months of age: Ask a doctor

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, dimethicone, glycerin, isotridectyl isononanoate, PEG-9 polydimethylsiloxyethyl dimethicone, disteardimonium hectorite, dimethicone/polyglycerin-3 crosspolymer, sodium chloride, phenoxyethanol, PEG-10 dimethicone, methylparaben, disodium stearoyl glutamate, silica silylate, chlorphenesin, fragrance, trisodium ethylenediamine disuccinate, tocopherol, ascorbyl palmitate, aluminum hydroxide, dipropylene glycol, BHT, alpha-isomethyl ionone; may contain: titanium dioxide, iron oxides

Description

Octinoxate 7%

Use
  • helps prevent sunburn
Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredient

Octinoxate 7%

Questions Or Comments?

1-800-322-2036

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

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

● children under 6 months of age: Ask a doctor

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, dimethicone, glycerin, isotridectyl isononanoate, PEG-9 polydimethylsiloxyethyl dimethicone, disteardimonium hectorite, dimethicone/polyglycerin-3 crosspolymer, sodium chloride, phenoxyethanol, PEG-10 dimethicone, methylparaben, disodium stearoyl glutamate, silica silylate, chlorphenesin, fragrance, trisodium ethylenediamine disuccinate, tocopherol, ascorbyl palmitate, aluminum hydroxide, dipropylene glycol, BHT, alpha-isomethyl ionone; may contain: titanium dioxide, iron oxides

Use
  • helps prevent sunburn
Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Octinoxate 7%

Questions Or Comments? (Questions or comments?)

1-800-322-2036

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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