drug facts

drug facts
SPL v12
SPL
SPL Set ID 8df98d97-a5d2-4d52-8bd2-130a13501d60
Route
topical
Published
Effective Date 2024-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (60 mg) zinc oxide (50 mg)
Inactive Ingredients
water dimethicone isododecane alkyl (c12-15) benzoate undecane triethylhexanoin isohexadecane nylon-12 caprylyl trisiloxane butyloctyl salicylate phenethyl benzoate styrene/acrylamide copolymer (500000 mw) silicon dioxide tridecane dicaprylyl carbonate dicaprylyl ether talc dimethicone/peg-10/15 crosspolymer aluminum stearate pentylene glycol peg-9 polydimethylsiloxyethyl dimethicone aluminum oxide polyhydroxystearic acid (2300 mw) phenoxyethanol magnesium sulfate, unspecified form caprylyl glycol ferric oxide red peg-8 laurate disteardimonium hectorite triethoxycaprylylsilane tocopherol propylene carbonate benzoic acid polyethylene glycol 450 disodium stearoyl glutamate aluminum hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2011-01-01

Purpose

Sunscreen

Description

Titanium dioxide 6% Zinc oxide 5%


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

● apply liberally 15 minutes before sun exposure

● reapply:

    ● after 40 minutes of swimming or sweating

    ● immediately after towel drying

    ● at least every 2 hours

● 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, dimethicone, isododecane, c12-15 alkyl benzoate, undecane, triethylhexanoin, isohexadecane, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, styrene/acrylates copolymer, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, caprylyl glycol, iron oxides, PEG-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane, tocopherol, propylene carbonate, artemia extract, benzoic acid, PEG-9, disodium stearoyl glutamate, aluminum hydroxide

Description

Titanium dioxide 6% Zinc oxide 5%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Titanium dioxide 6%

Zinc oxide 5%

Questions Or Comments?

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

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

● apply liberally 15 minutes before sun exposure

● reapply:

    ● after 40 minutes of swimming or sweating

    ● immediately after towel drying

    ● at least every 2 hours

● 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, dimethicone, isododecane, c12-15 alkyl benzoate, undecane, triethylhexanoin, isohexadecane, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, styrene/acrylates copolymer, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, caprylyl glycol, iron oxides, PEG-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane, tocopherol, propylene carbonate, artemia extract, benzoic acid, PEG-9, disodium stearoyl glutamate, aluminum hydroxide

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Titanium dioxide 6%

Zinc oxide 5%

Questions Or Comments? (Questions or comments?)

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

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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