Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0e9d006c-2ea0-8228-e063-6394a90a65d6
Route
TOPICAL
Published
Effective Date 2024-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (8.5 g) Titanium Dioxide (9.8 g)
Inactive Ingredients
Artemisia Vulgaris Whole Hyaluronic Acid Laminaria Digitata Vitamin A Palmitate .alpha.-tocopherol Acetate Coconut Alkanes Centella Asiatica Triterpenoids Olea Europaea Leaf Egg Phospholipids Isomalt Opuntia Ficus-indica Stem Beta Carotene Water Cyclomethicone 5 Squalane Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Glycerin Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Hexylene Glycol Hexyl Laurate Isohexadecane Polyglyceryl-4 Isostearate Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Aluminum Oxide Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Cyclomethicone 6 Magnesium Sulfate, Unspecified Mica Phenoxyethanol Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Caprylyl Glycol Dimethicone/peg-10/15 Crosspolymer Ethylhexylglycerin Glycyrrhizinate Dipotassium Perflunafene Zinc Pidolate Saccharomyces Lysate Xanthium Sibiricum Fruit Sodium Citrate Sodium Benzoate Salicylic Acid Lecithin, Soybean Sorbic Acid Tocopherol Wine Grape Acetyl Hexapeptide-8 Bismuth Oxychloride Hydrogen Dimethicone (13 Cst) Hydroxypropylcocoate Peg-8 Dimethicone Dimethicone Dipropylene Glycol Cyperus Rotundus Root Lonicera Japonica Flower Silicon Dioxide Ergothioneine Ferric Oxide Yellow Potassium Sorbate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Ferric Oxide Red Ferrosoferric Oxide Polyhydroxystearic Acid (2300 Mw) Leuconostoc/radish Root Ferment Filtrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-10

Description

Active Ingredient: Titanium Dioxide – 9.8 % Zinc Oxide - 8.5 %


Medication Information

Warnings and Precautions

Warnings • For external use only

Indications and Usage

Uses • helps prevent sunburn

Dosage and Administration

Directions • 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

• 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

Description

Active Ingredient: Titanium Dioxide – 9.8 % 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, Cyclopentasiloxane, Coconut Alkanes, Squalane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Isohexadecane, Polyglyceryl-4 Isostearate, Vinyl Dimethicone/Lauryl Dimethicone, Crosspolymer, Hydrogen Dimethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Dimethicone, Alumina, Polyglyceryl-3 Polydimthylsiloxyethyl Dimethicone, Cyclohexasiloxane, Magnesium Sulfate, Mica, Polyhydroxysteraic Acid, Phenoxyethanol, Triethoxysilyethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Dimethicone/PEG-10/15 Crosspolymer, Ethylhexylglycerin, Hexylene Glycol, Dipotassium Glycyrrhizate, Perflurorodecalin, Zinc PCA, Saccharomyces Lysate Extract, Centella Asiatica Extract, Leuconostoc/Radish Root Ferment Filtrate, Olea Europea (Olive) Leaf Extract, Artemisia Vulgaris Extract , Hyaluronic Acid, Laminaria Digitata Extract, Phospholipids, Isomalt, Cyperus Rotundus Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Xanthium Sibiricum Fruit Extract, Dipropylene Glycol, Retinyl Palmitate, Tococpheryl 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, [+/ -: Bismuth Oxychloride (Ci 77163),Iron Oxide (Ci 77492), Iron Oxide (Ci 77491), Iron Oxide (Ci77499)]

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredient:

Titanium Dioxide – 9.8 %

Zinc Oxide - 8.5 %

Section 60561-8

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

Dosage and Administration (34068-7)

Directions • 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

• 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

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, Cyclopentasiloxane, Coconut Alkanes, Squalane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Isohexadecane, Polyglyceryl-4 Isostearate, Vinyl Dimethicone/Lauryl Dimethicone, Crosspolymer, Hydrogen Dimethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Dimethicone, Alumina, Polyglyceryl-3 Polydimthylsiloxyethyl Dimethicone, Cyclohexasiloxane, Magnesium Sulfate, Mica, Polyhydroxysteraic Acid, Phenoxyethanol, Triethoxysilyethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Dimethicone/PEG-10/15 Crosspolymer, Ethylhexylglycerin, Hexylene Glycol, Dipotassium Glycyrrhizate, Perflurorodecalin, Zinc PCA, Saccharomyces Lysate Extract, Centella Asiatica Extract, Leuconostoc/Radish Root Ferment Filtrate, Olea Europea (Olive) Leaf Extract, Artemisia Vulgaris Extract , Hyaluronic Acid, Laminaria Digitata Extract, Phospholipids, Isomalt, Cyperus Rotundus Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Xanthium Sibiricum Fruit Extract, Dipropylene Glycol, Retinyl Palmitate, Tococpheryl 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, [+/ -: Bismuth Oxychloride (Ci 77163),Iron Oxide (Ci 77492), Iron Oxide (Ci 77491), Iron Oxide (Ci77499)]

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active Ingredient:

Titanium Dioxide – 9.8 %

Zinc Oxide - 8.5 %

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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