SPL v4
SPL
SPL Set ID f493c3ea-41b3-4625-84a6-fab545a76940
Route
TOPICAL
Published
Effective Date 2025-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (90 mg) Zinc Oxide (63 mg)
Inactive Ingredients
Water Phenyl Trimethicone Dimethicone Butylene Glycol Butylene Glycol Dicaprylate/dicaprate Butyloctyl Salicylate Cetyl Peg/ppg-10/1 Dimethicone (hlb 1.5) Cyclomethicone 5 Cyclomethicone 6 Magnesium Sulfate, Unspecified Form Polyglyceryl-4 Isostearate Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Aluminum Hydroxide Hexyl Laurate Stearic Acid Calcium Stearate Caprylyl Glycol Triethoxycaprylylsilane Ethylhexylglycerin Lemon Oil .alpha.-tocopherol Acetate, D- Sorbitan Isosteareth-5 Phenoxyethanol Bergamot Oil 1,2-hexanediol Edetate Disodium Orange Oil Lime Oil Grape Seed Oil Punica Granatum Seed Oil Pine Needle Oil (pinus Sylvestris) Avocado Oil Niacinamide Citrus Maxima Fruit Rind Oil Cholesterol Perflexane Glycerin Eucalyptus Oil Green Tea Leaf Perflunafene Steareth-20 Citric Acid Monohydrate Sodium Benzoate Potassium Sorbate Aloe Vera Leaf N-hydroxysuccinimide Caprylhydroxamic Acid Tocopherol Thiamine Hydrochloride Riboflavin Vitamin A Palmitate Pantothenic Acid Palmitoyl Tripeptide-1 Niacin Folic Acid Chrysin Levocarnitine Hydrochloride Biotin Ascorbic Acid Palmitoyl Tetrapeptide-7 Chlorhexidine Gluconate Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-03-05

Description

Titanium dioxide 9.0% Zinc oxide 6.3%%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 9.0% 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 9.0%

Zinc oxide 6.3%%

Inactive Ingredients

water, snail secretion filtrate, phenyl trimethicone, dimethicone, butylene glycol, butylene glycol dicaprylated/dicaprate, orbignya oleifera seed oil, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethiocone, cyclopentasiloxane, cyclohexasiloxane, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/vinyl dimethicone crosspolymer, aluminum hydroxide, hexyl laurate, stearic acid, calcium stearate, caprylyl glycol, triethoxycaprylylsilane, ethylhexylglycerin, citrus medica limonum (lemon) peel oil, tocopheryl acetate, sorbitan isostearate, phenoxyethanol, citrus aurantium bergamia (bergamot) fruit oil, 1,2-hexanediol, disodium EDTA, citrus aurantium dulcis (orange) peel oil, cirus aurantifolia (lime) oil, vitis vinifera (grape) seed oil, punica gratissiima (avocado) oil, niacinamide, citrus grandis (grapefuit) peel oil, chloesterol, anthemis nobilis flower water, lactobacillius/honeysuckle flowr/locorice root/morus alba root/pueraria lobata root/schizandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, perfluorohexane, olea europaea (olive) leaf extract, glycerin, eucalyptus globulus leaf oil, camellia sinensis leaf extract, chrysanthemium indicum flower extract, pueraria lobata root extract, perfluorodecalin, morus alba gruit extract, magnolia kobus bark extract, glycine soja (soybean) sprout extract, diospyros kaki leaf extract, cinnamomum cassia bark extract, artemisia princeps leaf extract, pentafluoropropane, curcuma longa (turmeric) root extract, steareth-20, hydrolyzed silk, hydrolyzed hyaluronic acid, colloidal oatmeal, citric acid, sodium benzoate, potassum sorbate, aloe barbadensis leaf extract, n-hydroxysuccinimide, hydrolyzed collagen, caprylhydroxamic acid, tocopherol, thiamine HCL, riboflavin, retinyl palmitate, pantothenic acid, palmitoyl oligopeptide, niacin, folic acid, chrysin, carnitine HCL, biotin, ascorbic acid, palmitoyl tetrapeptide-7, chlorhexidine digluconate; may contain: iron oxides

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 9.0%

Zinc oxide 6.3%%

Inactive Ingredients (Inactive ingredients)

water, snail secretion filtrate, phenyl trimethicone, dimethicone, butylene glycol, butylene glycol dicaprylated/dicaprate, orbignya oleifera seed oil, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethiocone, cyclopentasiloxane, cyclohexasiloxane, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/vinyl dimethicone crosspolymer, aluminum hydroxide, hexyl laurate, stearic acid, calcium stearate, caprylyl glycol, triethoxycaprylylsilane, ethylhexylglycerin, citrus medica limonum (lemon) peel oil, tocopheryl acetate, sorbitan isostearate, phenoxyethanol, citrus aurantium bergamia (bergamot) fruit oil, 1,2-hexanediol, disodium EDTA, citrus aurantium dulcis (orange) peel oil, cirus aurantifolia (lime) oil, vitis vinifera (grape) seed oil, punica gratissiima (avocado) oil, niacinamide, citrus grandis (grapefuit) peel oil, chloesterol, anthemis nobilis flower water, lactobacillius/honeysuckle flowr/locorice root/morus alba root/pueraria lobata root/schizandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, perfluorohexane, olea europaea (olive) leaf extract, glycerin, eucalyptus globulus leaf oil, camellia sinensis leaf extract, chrysanthemium indicum flower extract, pueraria lobata root extract, perfluorodecalin, morus alba gruit extract, magnolia kobus bark extract, glycine soja (soybean) sprout extract, diospyros kaki leaf extract, cinnamomum cassia bark extract, artemisia princeps leaf extract, pentafluoropropane, curcuma longa (turmeric) root extract, steareth-20, hydrolyzed silk, hydrolyzed hyaluronic acid, colloidal oatmeal, citric acid, sodium benzoate, potassum sorbate, aloe barbadensis leaf extract, n-hydroxysuccinimide, hydrolyzed collagen, caprylhydroxamic acid, tocopherol, thiamine HCL, riboflavin, retinyl palmitate, pantothenic acid, palmitoyl oligopeptide, niacin, folic acid, chrysin, carnitine HCL, biotin, ascorbic acid, palmitoyl tetrapeptide-7, chlorhexidine digluconate; may contain: iron oxides

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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)