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

Active Ingredient

Active Ingredient:

Titanium Dioxide – 9.8 %

Zinc Oxide - 8.5 %

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 60561-8

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


Structured Label Content

Warnings and Precautions (34071-1)

Warnings • For external use only

Active Ingredient (55106-9)

Active Ingredient:

Titanium Dioxide – 9.8 %

Zinc Oxide - 8.5 %

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

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 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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