Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID a31dacaa-738d-4da8-95b2-4d737c526683
Route
TOPICAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (10 mg) Titanium Dioxide (67 mg)
Inactive Ingredients
Water Glycerin Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-07-01

Description

Octinoxate 1% Titanium dioxide 6.7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 1% Titanium dioxide 6.7%

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

Section 51945-4

Warnings

For external use only

Directions

For sunscreen use:

● shake well before using

● 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

Do Not Use

on damaged or broken skin

Other Information

protect the product in this container from excessive heat and direct sun

Active Ingredients

Octinoxate 1%

Titanium dioxide 6.7%

Inactive Ingredients

water, isododecane, cyclopentasiloxane, glycerin, cyclohexasiloxane, PEG-10 dimethicone, methyl methacrylate crosspolymer, butylene glycol, dimethicone, isoeicosane, ascorbyl glucoside, disteardimonium hectorite, cetyl PEG/PPG-10/1 dimethicone, phenoxyethanol, sodium chloride, C9-15 fluoroalcohol phosphate, polyglyceryl-4 isostearate, hexyl laurate, caprylyl glycol, isostearyl neopentanoate, alumina, methylparaben, calcium pantetheine sulfonate, acetyl trifluoromethylphenyl valyglycine, hydroxypropyl tetrahydropyrantriol, pisum sativum (pea) extract, retinyl palmitate, silica dimethyl silylate, polycaprolactone, soluble collagen, sodium hyaluronate; may contain: titanium dioxide, iron oxides, mica

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

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

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

For sunscreen use:

● shake well before using

● 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

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

protect the product in this container from excessive heat and direct sun

Active Ingredients (Active ingredients)

Octinoxate 1%

Titanium dioxide 6.7%

Inactive Ingredients (Inactive ingredients)

water, isododecane, cyclopentasiloxane, glycerin, cyclohexasiloxane, PEG-10 dimethicone, methyl methacrylate crosspolymer, butylene glycol, dimethicone, isoeicosane, ascorbyl glucoside, disteardimonium hectorite, cetyl PEG/PPG-10/1 dimethicone, phenoxyethanol, sodium chloride, C9-15 fluoroalcohol phosphate, polyglyceryl-4 isostearate, hexyl laurate, caprylyl glycol, isostearyl neopentanoate, alumina, methylparaben, calcium pantetheine sulfonate, acetyl trifluoromethylphenyl valyglycine, hydroxypropyl tetrahydropyrantriol, pisum sativum (pea) extract, retinyl palmitate, silica dimethyl silylate, polycaprolactone, soluble collagen, sodium hyaluronate; may contain: titanium dioxide, iron oxides, mica

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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