drug facts

drug facts
SPL v10
SPL
SPL Set ID 28c51c59-dbfb-45e5-b536-6e5d5c5560d6
Route
topical
Published
Effective Date 2024-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (11.5 mg)
Inactive Ingredients
water glycerin pentylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2012-06-01

Purpose

Sunscreen

Description

Titanium dioxide 1.15%


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

● 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, ethylhexyl palmitate, glycerin, octyldodecanol, silica, pentylene glycol, octyldodecyl xyloside, phenoxyethanol, sodium acrylate/sodium acryloyldimethyl taurate copolymer, hydrogenated lecithin, isohexadecane, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-30 dipolyhydroxystearate, sodium dehydroacetate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, caprylyl glycol, disodium EDTA, citric acid, polysorbate 80, potassium sorbate, propylene glycol, methylisothiazolinone, chamomilla recutita (matricaria) flower extract, aloe barbadensis leaf extract; may contain: titanium dioxdie, iron oxides

Description

Titanium dioxide 1.15%

Use

helps prevent sunburn

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredient

Titanium dioxide 1.15%

Questions Or Comments?

1-800-944-0730

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

● 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, ethylhexyl palmitate, glycerin, octyldodecanol, silica, pentylene glycol, octyldodecyl xyloside, phenoxyethanol, sodium acrylate/sodium acryloyldimethyl taurate copolymer, hydrogenated lecithin, isohexadecane, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-30 dipolyhydroxystearate, sodium dehydroacetate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, caprylyl glycol, disodium EDTA, citric acid, polysorbate 80, potassium sorbate, propylene glycol, methylisothiazolinone, chamomilla recutita (matricaria) flower extract, aloe barbadensis leaf extract; may contain: titanium dioxdie, 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)

Titanium dioxide 1.15%

Questions Or Comments? (Questions or comments?)

1-800-944-0730

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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