SPL v2
SPL
SPL Set ID 30086b1e-d876-2528-e063-6294a90a4e9f
Route
TOPICAL
Published
Effective Date 2025-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (11.12 g)
Inactive Ingredients
Propylheptyl Caprylate Glyceryl Caprylate Soybean Tocopherol Ferric Oxide Red Oatmeal 1,2-hexanediol Dicaprylyl Ether Ferric Oxide Yellow Ethylhexylglycerin Caprylyl Glycol Poly(methyl Methacrylate; 450000 Mw) Polyglyceryl-2 Dipolyhydroxystearate Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Triethoxycaprylylsilane Isododecane Disteardimonium Hectorite Cyclomethicone 6 Magnesium Sulfate Anhydrous Butyloctyl Salicylate Aluminum Hydroxide Panthenol Titanium Dioxide Niacinamide Polymethylsilsesquioxane (11 Microns) Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Caprylyl Trisiloxane Rice Germ Hyaluronate Sodium Adenosine Propanediol Water

Identifiers & Packaging

Pill Appearance
Shape: oval Color: white Size: 150 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-11

Description

Active Ingredient-ZINC OXIDE 22.24%

Purpose

Purpose-Sunscreen, Uses-Helps prevent sunburn


Medication Information

Purpose

Purpose-Sunscreen, Uses-Helps prevent sunburn

Description

Active Ingredient-ZINC OXIDE 22.24%

Uses

Apply Liberally 15 minutes before sun exposure. Reapply at least every two hours, Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. T Decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1)Limited time in the sun, especially from 10am to 2pm. 2. sleeve shirts, pants, hats, and sunglasses. If product is swallowed medical help or contact a Poison Control Center right away

Warning

For external use only. Do not use on damaged skin & broken skin.

Do Not Use

Do not use on damaged skin, on broken skin

Otc Purpose

Purpose-Sunscreen, Uses-Helps prevent sunburn

Incations & Usage

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.

Inactive Ingredients

Inactive Ingredients-WATER, CYCLOHEXASILOXANE, BUTYLOCTYL SALICYLATE, PANTHENOL, PROPANEDIOL, ISODODECANE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DICAPRYLYL ETHER, PROPYLHEPTYL CAPRYLATE, NIACINAMIDE, CAPRYLYL METHICONE ,TITANIUM DIOXIDE, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM SULFATE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, IRON OXIDES(CI 77492), 1,2- HEXANEDIOL, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE ,POLYMETHYLSILSESQUIOXANE, IRON OXIDES(CI 77491), CAPRYLYL GLYCOL, GLYCERYL CAPRYLA POLYMETHYL METHACRYLATE, ALUMINUM HYDROXIDE, ETHYLHEXYLGLYCERIN, ADENOSINE, IRON OXIDES(CI 77499), SODIUM HYALURONATE, TOCOPHEROL O SATIVA (RICE) EXTRACT, AVENA SATIVA (OAT) MEAL EXTRACT, GLYCINE MAX (SOYBEAN) SEED EXTRACT

Otc Active Ingredient

Active Ingredient-ZINC OXIDE 22.24%

Dosage & Administration

Dosage & administration -Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

Other Safety Information

Other Safety Information-Protect the product in this container from excessive heat and direct sun

Keep Out of Reach of Children

Keep Out Of Reach of Children- If product is swallowed, get medical help or contact a Poison Control Center right away

Package Label Principal Display Panel

Package Label Principal Display Panel-Thank Farmer, SPF40 Broad Spectrum, Sun Project Rice Tinted Mineral Sinscren, SPF40 Broad Spectrum, 1.69 FL.OZ/50ml


Structured Label Content

Uses (USES)

Apply Liberally 15 minutes before sun exposure. Reapply at least every two hours, Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. T Decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1)Limited time in the sun, especially from 10am to 2pm. 2. sleeve shirts, pants, hats, and sunglasses. If product is swallowed medical help or contact a Poison Control Center right away

Warning

For external use only. Do not use on damaged skin & broken skin.

Do Not Use

Do not use on damaged skin, on broken skin

Otc Purpose (OTC-Purpose)

Purpose-Sunscreen, Uses-Helps prevent sunburn

Incations & Usage (Incations & usage)

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.

Inactive Ingredients

Inactive Ingredients-WATER, CYCLOHEXASILOXANE, BUTYLOCTYL SALICYLATE, PANTHENOL, PROPANEDIOL, ISODODECANE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DICAPRYLYL ETHER, PROPYLHEPTYL CAPRYLATE, NIACINAMIDE, CAPRYLYL METHICONE ,TITANIUM DIOXIDE, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM SULFATE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, IRON OXIDES(CI 77492), 1,2- HEXANEDIOL, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE ,POLYMETHYLSILSESQUIOXANE, IRON OXIDES(CI 77491), CAPRYLYL GLYCOL, GLYCERYL CAPRYLA POLYMETHYL METHACRYLATE, ALUMINUM HYDROXIDE, ETHYLHEXYLGLYCERIN, ADENOSINE, IRON OXIDES(CI 77499), SODIUM HYALURONATE, TOCOPHEROL O SATIVA (RICE) EXTRACT, AVENA SATIVA (OAT) MEAL EXTRACT, GLYCINE MAX (SOYBEAN) SEED EXTRACT

Otc Active Ingredient (OTC Active Ingredient)

Active Ingredient-ZINC OXIDE 22.24%

Dosage & Administration (Dosage & administration)

Dosage & administration -Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

Other Safety Information

Other Safety Information-Protect the product in this container from excessive heat and direct sun

Keep Out of Reach of Children (Keep Out Of Reach of Children)

Keep Out Of Reach of Children- If product is swallowed, get medical help or contact a Poison Control Center right away

Package Label Principal Display Panel

Package Label Principal Display Panel-Thank Farmer, SPF40 Broad Spectrum, Sun Project Rice Tinted Mineral Sinscren, SPF40 Broad Spectrum, 1.69 FL.OZ/50ml


Advanced Ingredient Data


Raw Label Data

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