Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 4a243c9f-ca88-47fb-8777-1da79c001c73
Route
TOPICAL
Published
Effective Date 2024-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (90 mg) Zinc Cation (70 mg)
Inactive Ingredients
Water Glycerin Alkyl (c12-15) Benzoate Dimethicone Glyceryl Monostearate Isododecane Butyloctyl Salicylate Dicaprylyl Carbonate Propanediol Stearic Acid Aluminum Hydroxide Peg-100 Stearate Sorbitan Monostearate Peg-8 Laurate Ceramide Np Ceramide Ap Ceramide 1 Sorbitan Isostearate Carboxypolymethylene Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Triethoxycaprylylsilane Sodium Citrate Sodium Lauroyl Lactylate Sodium Dodecylbenzenesulfonate Myristic Acid Hyaluronate Sodium Cholesterol Palmitic Acid Phenoxyethanol Chlorphenesin Tocopherol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Caprylyl Glycol Citric Acid Monohydrate Xanthan Gum Phytosphingosine Polyhydroxystearic Acid (2300 Mw) Polysorbate 60 Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-01

Description

Titanium dioxide 9% Zinc oxide 7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 9% Zinc oxide 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:

• 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:

   o limit time in the sun, especially from 10 a.m. – 2 p.m.

   o 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

Titanium dioxide 9%

Zinc oxide 7%

Inactive Ingredients

water, glycerin, C12-15 alkyl benzoate, dimethicone, isododecane, styrene/acrylates copolymer, glyceryl stearate, butyloctyl salicylate, dicaprylyl carbonate, propanediol, stearic acid, aluminum hydroxide, PEG-100 stearate, sorbitan stearate, PEG-8 laurate, ceramide NP, ceramide AP, ceramide EOP, sorbitan isostearate, carbomer, cetearyl alcohol, cetearth-20, triethoxycaprylylsilane, dimethiconol, sodium citrate, sodium lauroyl lactylate, sodium dodecylbenzenesulfonate, myristic acid, sodium hyaluronate, cholesterol, palmitic acid, phenoxyethanol, chlorphenesin, tocopherol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, caprylyl glycol, citric acid, xanthan gum, phytosphinfosine, polyhydroxystearic acid, polysorbate 60, ethylhexylglycerin

Questions Or Comments?

Toll-free number 1-888-768-2915

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:

• 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:

   o limit time in the sun, especially from 10 a.m. – 2 p.m.

   o 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)

Titanium dioxide 9%

Zinc oxide 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, C12-15 alkyl benzoate, dimethicone, isododecane, styrene/acrylates copolymer, glyceryl stearate, butyloctyl salicylate, dicaprylyl carbonate, propanediol, stearic acid, aluminum hydroxide, PEG-100 stearate, sorbitan stearate, PEG-8 laurate, ceramide NP, ceramide AP, ceramide EOP, sorbitan isostearate, carbomer, cetearyl alcohol, cetearth-20, triethoxycaprylylsilane, dimethiconol, sodium citrate, sodium lauroyl lactylate, sodium dodecylbenzenesulfonate, myristic acid, sodium hyaluronate, cholesterol, palmitic acid, phenoxyethanol, chlorphenesin, tocopherol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, caprylyl glycol, citric acid, xanthan gum, phytosphinfosine, polyhydroxystearic acid, polysorbate 60, ethylhexylglycerin

Questions Or Comments? (Questions or comments?)

Toll-free number 1-888-768-2915

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.


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