20a44597-3d44-f0ea-e063-6294a90a903d

SPL v5
SPL
SPL Set ID 20a44597-3d44-f0ea-e063-6294a90a903d
Route
topical
Published
Effective Date 2024-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (11.12 g)
Inactive Ingredients
ethylhexylglycerin caprylyl glycol oatmeal isododecane 1,2-hexanediol niacinamide disteardimonium hectorite cyclomethicone 6 caprylyl trisiloxane triethoxycaprylylsilane adenosine magnesium sulfate anhydrous propanediol dicaprylyl ether butyloctyl salicylate propylheptyl caprylate rice germ aluminum hydroxide polymethylsilsesquioxane (11 microns) poly(methyl methacrylate; 450000 mw) panthenol glyceryl caprylate hyaluronate sodium water titanium dioxide polyglyceryl-2 dipolyhydroxystearate soybean tocopherol ferric oxide red polyglyceryl-3 polydimethylsiloxyethyl dimethicone (4000 mpa.s) ferric oxide yellow

Identifiers & Packaging

Pill Appearance
Shape: oval Color: white Size: 150 mm
Marketing Status
otc monograph drug active Since 2024-09-16

Purpose

Purpose-Sunscreen, Uses-Helps prevent sunburn

Description

Active Ingredient-ZINC OXIDE 22.24%


Medication Information

Purpose

Purpose-Sunscreen, Uses-Helps prevent sunburn

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 CAPRYLATE, POLYMETHYL METHACRYLATE, ALUMINUM HYDROXIDE, ETHYLHEXYLGLYCERIN, ADENOSINE, IRON OXIDES(CI 77499), SODIUM HYALURONATE, TOCOPHEROL ORYZA SATIVA (RICE) EXTRACT, AVENA SATIVA (OAT) MEAL EXTRACT, GLYCINE MAX (SOYBEAN) SEED EXTRACT

Description

Active Ingredient-ZINC OXIDE 22.24%

Warning

For external use only

Do Not Use

Do not use on damaged skin, on broken skin

When Using

When using this product, keep out of eyes. Rinse with water to remove

Active Ingredient

Active Ingredient-ZINC OXIDE 22.24%

Incations & Usage

Incations & usage-Helps prevent sunburn

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 you Farmer, SPF40 Broad Spectrum, Sun Project Rice Tinted Mineral Sinscren, SPF40 Broad Spectrum, 1.69 FL.OZ/50ml

Ask A Doctor to Use for Children Under 6 Months

Ask a doctor to use for children under 6 months


Structured Label Content

Purpose

Purpose-Sunscreen, Uses-Helps prevent sunburn

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 CAPRYLATE, POLYMETHYL METHACRYLATE, ALUMINUM HYDROXIDE, ETHYLHEXYLGLYCERIN, ADENOSINE, IRON OXIDES(CI 77499), SODIUM HYALURONATE, TOCOPHEROL ORYZA SATIVA (RICE) EXTRACT, AVENA SATIVA (OAT) MEAL EXTRACT, GLYCINE MAX (SOYBEAN) SEED EXTRACT

Warning

For external use only

Do Not Use

Do not use on damaged skin, on broken skin

When Using (When using)

When using this product, keep out of eyes. Rinse with water to remove

Active Ingredient

Active Ingredient-ZINC OXIDE 22.24%

Incations & Usage (Incations & usage)

Incations & usage-Helps prevent sunburn

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 you Farmer, SPF40 Broad Spectrum, Sun Project Rice Tinted Mineral Sinscren, SPF40 Broad Spectrum, 1.69 FL.OZ/50ml

Ask A Doctor to Use for Children Under 6 Months (Ask a doctor to use for children under 6 months)

Ask a doctor to use for children under 6 months


Advanced Ingredient Data


Raw Label Data

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