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

Purpose

Sunscreen

Description

Octinoxate 1% Titanium dioxide 6.7%


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 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

Other Information

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

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

Description

Octinoxate 1% Titanium dioxide 6.7%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Octinoxate 1%

Titanium dioxide 6.7%

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 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

Other Information (Other information)

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

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

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Octinoxate 1%

Titanium dioxide 6.7%

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

All Sections (JSON)