Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 86eea4df-4191-4e05-9f05-4a98ef8c2a4d
Route
TOPICAL
Published
Effective Date 2025-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (90 mg) Zinc Cation (63 mg)
Inactive Ingredients
Water Phenyl Trimethicone Dimethicone Butylene Glycol Butylene Glycol Dicaprylate/dicaprate Babassu Oil Butyloctyl Salicylate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Cyclomethicone 5 Snail Secretion Filtrate Aluminum Hydroxide Magnesium Sulfate, Unspecified Form Polyglyceryl-4 Isostearate Stearic Acid Cyclomethicone 6 Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Hexyl Laurate Calcium Stearate Caprylyl Glycol Triethoxycaprylylsilane Ethohexadiol Ethylhexylglycerin Limonene, (+)- Lemon Oil Sorbitan Isostearate .alpha.-tocopherol Acetate Phenoxyethanol 1,2-hexanediol Bergamot Oil Adenosine Orange Oil Lime Oil Pine Needle Oil (pinus Sylvestris) Niacinamide Polymethylsilsesquioxane (4.5 Microns) Propylene Glycol Linalool, (+/-)- Glycerin Eucalyptus Globulus Leaf Oil Citral Leuconostoc/radish Root Ferment Filtrate Asian Ginseng Cocos Nucifera (coconut) Fruit Hydroxyethylcellulose Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Camellia Sinensis Leaf Silk, Base Hydrolyzed (1000 Mw) Sodium Citrate Citric Acid Steareth-20 Potassium Sorbate Adzuki Bean Limosilactobacillus Fermentum Xanthan Gum Diamond Powder Olea Europaea (olive) Leaf Chlorhexidine Digluconate N-hydroxysuccinimide Biotin Palmitoyl Tripeptide-1 Chrysin Palmitoyl Tetrapeptide-7 Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-15

Description

Titanium dioxide 9% Zinc oxide  6.3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 9% Zinc oxide  6.3%

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:

   ● 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

Titanium dioxide 9%

Zinc oxide  6.3%

Inactive Ingredients

G2026415: water, phenyl trimethicone, dimethicone, butylene glycol, butylene glycol dicaprylate/dicaprate, orbignya oleifera seed oil, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, cyclopentasiloxane, snail secretion filtrate, aluminum hydroxide, magnesium sulfate, polyglyceryl-4 isostearate, stearic acid, cyclohexasiloxane, dimethicone/vinyl dimethicone crosspolymer, hexyl laurate, calcium stearate, caprylyl glycol, triethoxycaprylylsilane, ethyl hexanediol, ethylhexylglycerin, limonene, citrus limon (lemon) peel oil, sorbitan isostearate, tocopheryl acetate, phenoxyethanol, 1,2-hexanediol, citrus aurantium bergamia (bergamot) fruit oil, adenosine, citrus aurantium dulcis (orange) peel oil, citrus aurantifolia (lime) oil, pinus sylvestris leaf oil, niacinamide, polymethylsilsesquioxane, lactobacillus/dipteryx odorata seed ferment filtrate, lactobacillus/pumpkin ferment extract, propylene glycol, saccharomyces/xylinum/black tea ferment, linalool, glycerin, eucalyptus globulus leaf oil, saccharomyces/rice ferment filtrate, lactobacillus/kelp ferment filtrate, citral, hydrolyzed collagen, leuconostoc/radish root ferment filtrate, panax ginseng root extract, cocos nucifera (coconut) fruit extract, hydroxyethylcellulose, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, camellia sinensis leaf extract, silk extract, hydrolyzed silk, sodium citrate, citric acid, steareth-20, potassium sorbate, saccharomyces/camellia sinensis extract ferment filtrate, bacillus/cordyceps sinensis/ganoderma lucidum/inonotus obliquus/lentinus edodes/phellinus linteus/schizophyllum commune/tricholoma matsutake extract ferment filtrate, phaseolus angularis seed extract, lactobacillus ferment, lactobacillus/centella asiatica/gleditsia sinensis thorn/houttuynia cordata extract/phellodendron amurense bark/polygonum cuspidatum root/prunella vulgaris/torilis japonica extract ferment filtrate, lactobacillus/rice ferment filtrate, xanthan gum, diamond powder, olea europaea (olive) leaf extract, chlorhexidine digluconate, n-hydroxysuccinimide, biotin, palmitoyl tripeptide-1, hydrolyzed hyaluronic acid, chrysin, palmitoyl tetrapeptide-7. May contain: iron oxides, titanium dioxide.

Questions Or Comments?

Call 800-620-3950

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:

   ● 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)

Titanium dioxide 9%

Zinc oxide  6.3%

Inactive Ingredients (Inactive ingredients)

G2026415: water, phenyl trimethicone, dimethicone, butylene glycol, butylene glycol dicaprylate/dicaprate, orbignya oleifera seed oil, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, cyclopentasiloxane, snail secretion filtrate, aluminum hydroxide, magnesium sulfate, polyglyceryl-4 isostearate, stearic acid, cyclohexasiloxane, dimethicone/vinyl dimethicone crosspolymer, hexyl laurate, calcium stearate, caprylyl glycol, triethoxycaprylylsilane, ethyl hexanediol, ethylhexylglycerin, limonene, citrus limon (lemon) peel oil, sorbitan isostearate, tocopheryl acetate, phenoxyethanol, 1,2-hexanediol, citrus aurantium bergamia (bergamot) fruit oil, adenosine, citrus aurantium dulcis (orange) peel oil, citrus aurantifolia (lime) oil, pinus sylvestris leaf oil, niacinamide, polymethylsilsesquioxane, lactobacillus/dipteryx odorata seed ferment filtrate, lactobacillus/pumpkin ferment extract, propylene glycol, saccharomyces/xylinum/black tea ferment, linalool, glycerin, eucalyptus globulus leaf oil, saccharomyces/rice ferment filtrate, lactobacillus/kelp ferment filtrate, citral, hydrolyzed collagen, leuconostoc/radish root ferment filtrate, panax ginseng root extract, cocos nucifera (coconut) fruit extract, hydroxyethylcellulose, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, camellia sinensis leaf extract, silk extract, hydrolyzed silk, sodium citrate, citric acid, steareth-20, potassium sorbate, saccharomyces/camellia sinensis extract ferment filtrate, bacillus/cordyceps sinensis/ganoderma lucidum/inonotus obliquus/lentinus edodes/phellinus linteus/schizophyllum commune/tricholoma matsutake extract ferment filtrate, phaseolus angularis seed extract, lactobacillus ferment, lactobacillus/centella asiatica/gleditsia sinensis thorn/houttuynia cordata extract/phellodendron amurense bark/polygonum cuspidatum root/prunella vulgaris/torilis japonica extract ferment filtrate, lactobacillus/rice ferment filtrate, xanthan gum, diamond powder, olea europaea (olive) leaf extract, chlorhexidine digluconate, n-hydroxysuccinimide, biotin, palmitoyl tripeptide-1, hydrolyzed hyaluronic acid, chrysin, palmitoyl tetrapeptide-7. May contain: iron oxides, titanium dioxide.

Questions Or Comments? (Questions or comments?)

Call 800-620-3950

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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