Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 34f0c2c9-a5bc-4b25-bfc1-336dcbb353e4
Route
TOPICAL
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (89 mg) Zinc Oxide (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 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, (+)- Phenoxyethanol Lemon Oil Sorbitan Isostearate .alpha.-tocopherol Acetate 1,2-hexanediol Bergamot Oil Edetate Disodium Orange Oil Lime Oil Pine Needle Oil (pinus Sylvestris) Niacinamide Punica Granatum Seed Oil Grape Seed Oil Cholesterol Cholesteryl Oleyl Carbonate Avocado Oil Polymethylsilsesquioxane (4.5 Microns) Chamaemelum Nobile Flower Oil Linalool, (+/-)- Asian Ginseng Oat Eucalyptus Oil Cholesteryl Isostearate Citral Cholesteryl Chloride Cholesteryl Nonanoate Turmeric Perflexane Glycerin Leuconostoc/radish Root Ferment Filtrate Magnolia Kobus Bark Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Green Tea Leaf Soybean Perflunafene Perfluoromethylcyclopentane Silica Dimethyl Silylate Steareth-20 Citric Acid Monohydrate Sugarcane Coconut Adzuki Bean Lactobacillus Fermentum Sodium Benzoate Chrysanthemum Indicum Flower Potassium Sorbate Butylated Hydroxytoluene Diamond Aloe Vera Leaf Caprylhydroxamic Acid Olea Europaea Leaf Artemisia Princeps Leaf Chinese Cinnamon Pueraria Montana Var. Lobata Root Diospyros Kaki Leaf White Mulberry Chlorhexidine Gluconate N-hydroxysuccinimide Biotin Thiamine Hydrochloride Niacin Folic Acid Vitamin A Palmitate Levocarnitine Hydrochloride Riboflavin Tocopherol Ascorbic Acid Pantothenic Acid Sodium Citrate Palmitoyl Tripeptide-1 Chrysin Palmitoyl Tetrapeptide-7 Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-01

Description

Titanium dioxide 8.9% Zinc oxide  6.3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 8.9% 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

● shake well before 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 8.9%

Zinc oxide  6.3%

Inactive Ingredients

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, phenoxyethanol, citrus limon (lemon) peel oil, sorbitan isostearate, tocopheryl acetate, 1,2-hexanediol, citrus aurantium bergamia (bergamot) fruit oil, disodium EDTA, citrus aurantium dulcis (orange) peel oil, citrus aurantifolia (lime) oil, pinus sylvestris leaf oil, niacinamide, punica granatum seed oil, vitis vinifera (grape) seed oil, cholesterol, cholesteryl oleyl carbonate, persea gratissima (avocado) oil, polymethylsilsesquioxane, anthemis nobilis flower water, lactobacillus/dipteryx odorata seed ferment filtrate, lactobacillus/pumpkin ferment extract, linalool, panax ginseng root extract, avena sativa (oat) kernel extract, eucalyptus globulus leaf oil, saccharomyces/rice ferment filtrate, lactobacillus/kelp ferment filtrate, cholesteryl isostearate, citral, cholesteryl chloride, cholesteryl nonanoate, curcuma longa (turmeric) root extract, perfluorohexane, glycerin, leuconostoc/radish root ferment filtrate, magnolia kobus bark extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, camellia sinensis leaf extract, glycine soja (soybean) sprout extract, perfluorodecalin, silk extract, hydrolyzed silk, perfluoromethylcyclopentane, silica, steareth-20, citric acid, saccharum officinarum (sugarcane) extract, cocos nucifera (coconut) fruit extract, hydrolyzed collagen, 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, sodium benzoate, chrysanthemum indicum flower extract, potassium sorbate, BHT, diamond powder, lactobacillus/honeysuckle flower/licorice root/morus alba root/pueraria lobata root/schisandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, aloe barbadensis leaf extract, caprylhydroxamic acid, olea europaea (olive) leaf extract, artemisia princeps leaf extract, cinnamomum cassia bark extract, pueraria lobata root extract, diospyros kaki leaf extract, morus alba fruit extract, chlorhexidine digluconate, n-hydroxysuccinimide, biotin, thiamine HCL, niacin, folic acid, retinyl palmitate, carnitine HCL, riboflavin, tocopherol, ascorbic acid, pantothenic acid, sodium citrate, palmitoyl tripeptide-1, hydrolyzed hyaluronic acid, chrysin, palmitoyl tetrapeptide-7; may contain: titanium dioxide, iron oxides

Questions Or Comments?

Call 800-620-3956

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

● shake well before 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 8.9%

Zinc oxide  6.3%

Inactive Ingredients (Inactive ingredients)

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, phenoxyethanol, citrus limon (lemon) peel oil, sorbitan isostearate, tocopheryl acetate, 1,2-hexanediol, citrus aurantium bergamia (bergamot) fruit oil, disodium EDTA, citrus aurantium dulcis (orange) peel oil, citrus aurantifolia (lime) oil, pinus sylvestris leaf oil, niacinamide, punica granatum seed oil, vitis vinifera (grape) seed oil, cholesterol, cholesteryl oleyl carbonate, persea gratissima (avocado) oil, polymethylsilsesquioxane, anthemis nobilis flower water, lactobacillus/dipteryx odorata seed ferment filtrate, lactobacillus/pumpkin ferment extract, linalool, panax ginseng root extract, avena sativa (oat) kernel extract, eucalyptus globulus leaf oil, saccharomyces/rice ferment filtrate, lactobacillus/kelp ferment filtrate, cholesteryl isostearate, citral, cholesteryl chloride, cholesteryl nonanoate, curcuma longa (turmeric) root extract, perfluorohexane, glycerin, leuconostoc/radish root ferment filtrate, magnolia kobus bark extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, camellia sinensis leaf extract, glycine soja (soybean) sprout extract, perfluorodecalin, silk extract, hydrolyzed silk, perfluoromethylcyclopentane, silica, steareth-20, citric acid, saccharum officinarum (sugarcane) extract, cocos nucifera (coconut) fruit extract, hydrolyzed collagen, 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, sodium benzoate, chrysanthemum indicum flower extract, potassium sorbate, BHT, diamond powder, lactobacillus/honeysuckle flower/licorice root/morus alba root/pueraria lobata root/schisandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, aloe barbadensis leaf extract, caprylhydroxamic acid, olea europaea (olive) leaf extract, artemisia princeps leaf extract, cinnamomum cassia bark extract, pueraria lobata root extract, diospyros kaki leaf extract, morus alba fruit extract, chlorhexidine digluconate, n-hydroxysuccinimide, biotin, thiamine HCL, niacin, folic acid, retinyl palmitate, carnitine HCL, riboflavin, tocopherol, ascorbic acid, pantothenic acid, sodium citrate, palmitoyl tripeptide-1, hydrolyzed hyaluronic acid, chrysin, palmitoyl tetrapeptide-7; may contain: titanium dioxide, iron oxides

Questions Or Comments? (Questions or comments?)

Call 800-620-3956

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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