Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID dcba05ff-7a68-c5c0-e053-2a95a90a6129
Route
TOPICAL
Published
Effective Date 2022-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (85 mg) Titanium Dioxide (65 mg)
Inactive Ingredients
Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Glycerin Artemisia Vulgaris Whole Glycyrrhizinate Dipotassium Perflunafene Zinc Pidolate Centella Asiatica Triterpenoids Leuconostoc/radish Root Ferment Filtrate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Ferrosoferric Oxide Dimethicone/peg-10/15 Crosspolymer Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Hydroxypropylcocoate Peg-8 Dimethicone Phenoxyethanol Ergothioneine Bismuth Oxychloride Omega-3 Fatty Acids Coconut Alkanes Polyhydroxystearic Acid (2300 Mw) Ethylhexylglycerin Hexylene Glycol Cyperus Rotundus Root Lonicera Japonica Flower Xanthium Sibiricum Fruit Dipropylene Glycol Vitamin A Palmitate .alpha.-tocopherol Acetate Opuntia Ficus-indica Stem Sodium Citrate Beta Carotene Salicylic Acid Acetyl Hexapeptide-8 Sorbic Acid Lecithin, Soybean Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Hexyl Laurate Isohexadecane Polyglyceryl-4 Isostearate Hydrogen Dimethicone (13 Cst) Cyclomethicone 6 Magnesium Sulfate, Unspecified Saccharomyces Lysate Water Potassium Sorbate Vitis Vinifera Anthocyanins Cyclomethicone 5 Silicon Dioxide Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Caprylyl Glycol Olea Europaea Leaf Laminaria Digitata Isomalt Ferric Oxide Yellow Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Mica Ascorbyl Palmitate Sodium Benzoate Dimethicone Aluminum Oxide Squalane Hyaluronic Acid Tocopherol Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-18

Description

Active Ingredients Titanium Dioxide 6.5% Zinc Oxide 8.5%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

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.

Dosage and Administration

Directions For Sunscreen Use • Apply generously 15 minutes before sun exposure. • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours. • Use a water resistant sunscreen if swimming or sweating: • immediately after towel drying. • at least every 2 hours.

Description

Active Ingredients Titanium Dioxide 6.5% Zinc Oxide 8.5%

Section 50565-1

Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if • Rash occurs.

Section 50567-7

When using this product

Keep out of eyes. Rinse with water to remove

Section 50570-1

Do not use

On damaged or broken skin.

Section 51727-6

Inactive Ingredients Water/Aqua/Eau, Coconut Alkanes, Cyclopentasiloxane, Squalane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, lsohexadecane, Polyglyceryl-4 Isostearate, Vinyl Dimethicone/Lauryl Dimethicone Crosspolymer, Hydrogen Dimethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Dimethicone, Alumina, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclohexasiloxane, Magnesium Sulfate, Mica, Polyhydroxystearic Acid, Phenoxyethanol, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Dimethicone/PEG-10/15 Crosspolymer, Ettylhexylglycerin, Hexylene Glycol, Dipotassium Glycyrrhizate, Perfluorodecalin, Zinc PCA, Saccharomyces Lysate Extract, Centella Asiatica Extract, Leuconostoc/Radish Root Ferment Filtrate, Olea Europaea (Olive) Leaf Extract, Artemisia Vulgads Extract, Hyaluronic Acid, Laminaria Digitata Extract, Phospholipids, lsomalt, Cyperus Rotundus Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Xanthium Sibiricum Fruit Extract, Dipropylene Glycol, Retinyl PaImitate, Ascorbyl Palmitate, Tocopheryl Acetate, Opuntia Ficus-Indica Stem Extract, Sodium Citrate, Sodium Benzoate, Beta-Carotene, Potassium Sorbate, Salicylic Acid, Acetyl Hexapeptide-8, Sorbic Acid, Tocopherol, Lecithin, Vitis Vinifera (Grape) Fruit Cell Extract, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Ergothioneine, Iron Oxides (CI 77492), Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredients

Titanium Dioxide 6.5%

Zinc Oxide 8.5%

Section 60561-8

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.

Other information • Protect the product in this container from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

Directions For Sunscreen Use • Apply generously 15 minutes before sun exposure. • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours. • Use a water resistant sunscreen if swimming or sweating: • immediately after towel drying. • at least every 2 hours.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if • Rash occurs.

Section 50567-7 (50567-7)

When using this product

Keep out of eyes. Rinse with water to remove

Section 50570-1 (50570-1)

Do not use

On damaged or broken skin.

Section 51727-6 (51727-6)

Inactive Ingredients Water/Aqua/Eau, Coconut Alkanes, Cyclopentasiloxane, Squalane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, lsohexadecane, Polyglyceryl-4 Isostearate, Vinyl Dimethicone/Lauryl Dimethicone Crosspolymer, Hydrogen Dimethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Dimethicone, Alumina, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclohexasiloxane, Magnesium Sulfate, Mica, Polyhydroxystearic Acid, Phenoxyethanol, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Dimethicone/PEG-10/15 Crosspolymer, Ettylhexylglycerin, Hexylene Glycol, Dipotassium Glycyrrhizate, Perfluorodecalin, Zinc PCA, Saccharomyces Lysate Extract, Centella Asiatica Extract, Leuconostoc/Radish Root Ferment Filtrate, Olea Europaea (Olive) Leaf Extract, Artemisia Vulgads Extract, Hyaluronic Acid, Laminaria Digitata Extract, Phospholipids, lsomalt, Cyperus Rotundus Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Xanthium Sibiricum Fruit Extract, Dipropylene Glycol, Retinyl PaImitate, Ascorbyl Palmitate, Tocopheryl Acetate, Opuntia Ficus-Indica Stem Extract, Sodium Citrate, Sodium Benzoate, Beta-Carotene, Potassium Sorbate, Salicylic Acid, Acetyl Hexapeptide-8, Sorbic Acid, Tocopherol, Lecithin, Vitis Vinifera (Grape) Fruit Cell Extract, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Ergothioneine, Iron Oxides (CI 77492), Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Titanium Dioxide 6.5%

Zinc Oxide 8.5%

Section 60561-8 (60561-8)

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.

Other information • Protect the product in this container from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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