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

Purpose

Sunscreen

Description

Titanium dioxide 9% Zinc oxide  6.3%


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:

● 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

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.

Description

Titanium dioxide 9% Zinc oxide  6.3%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Titanium dioxide 9%

Zinc oxide  6.3%

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

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:

● 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)

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.

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Titanium dioxide 9%

Zinc oxide  6.3%

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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