Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID dc792777-d8b6-3ebc-e053-2a95a90abc3f
Route
TOPICAL
Published
Effective Date 2022-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (85 mg) Titanium Dioxide (58 mg)
Inactive Ingredients
Squalane Isohexadecane Opuntia Ficus-indica Stem Sodium Citrate Hexyl Laurate Beta Carotene Salicylic Acid Ergothioneine Ferric Oxide Yellow Bismuth Oxychloride Hydroxypropylcocoate Peg-8 Dimethicone Artemisia Vulgaris Whole Cyperus Rotundus Root Xanthium Sibiricum Fruit Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Dimethicone Laminaria Digitata Omega-3 Fatty Acids .alpha.-tocopherol Acetate Perflunafene Leuconostoc/radish Root Ferment Filtrate Glycerin Silicon Dioxide Dimethicone/peg-10/15 Crosspolymer Wine Grape Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Aluminum Oxide Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Cyclomethicone 6 Dipropylene Glycol Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Hydrogen Dimethicone (13 Cst) Ethylhexylglycerin Acetyl Hexapeptide-8 Sorbic Acid Tocopherol Olea Europaea Leaf Caprylyl Glycol Hexylene Glycol Zinc Pidolate Hyaluronic Acid Isomalt Ascorbyl Palmitate Lecithin, Soybean Ferrosoferric Oxide Vitamin A Palmitate Centella Asiatica Triterpenoids Magnesium Sulfate, Unspecified Mica Glycyrrhizinate Dipotassium Lonicera Japonica Flower Saccharomyces Lysate Polyglyceryl-4 Isostearate Polyhydroxystearic Acid (2300 Mw) Phenoxyethanol Ferric Oxide Red Potassium Sorbate Sodium Benzoate Water Coconut Alkanes Cyclomethicone 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-12

Description

Active Ingredient Titanium Dioxide 5.8 % Zinc Oxide 8.5 %


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

Help prevent sunburn

If used as dircted 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 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 Ingredient Titanium Dioxide 5.8 % 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 aske 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

AQUA/WATER/EAU,COCONUT ALKANES,

CYCLOPENTASILOXANE,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 POLYDIMETHYLSILOXYETHYL DIMETHICONE,

CYCLOHEXASILOXANE,MAGNESIUM SULFATE,MICA,

POLYHYDROXYSTEARIC ACID,PHENOXYETHANOL,

TRIETHOXYSIMETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE,

CAPRYLYL GLYCOL,DIMETHICONE/PEG-10/15 CROSSPOLYMER,

ETHYLHEXYLGLYCERIN,HEXYLENE GLYCOL,DIPOTASSIUM GLYCYRRHIZATE,

PERFLUORODECALIN,ZINC PCA,SACCHAROMYCES LYSATE EXTRACT,

CENTELLA ASIATICA EXTRACT,LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE,

OLEA EUROPAEA (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,

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 Ingredient

Titanium Dioxide 5.8 %

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 suncreen with a broad spectrum SPF valu of 15 or higer and other sun protection

measures including

limit time in the sun,especially from 10 am -2 pm

wear long sleeved shirts, pants,hats and sunglassess

Other information

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


Structured Label Content

Indications and Usage (34067-9)

Uses

Help prevent sunburn

If used as dircted 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 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 aske 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)

AQUA/WATER/EAU,COCONUT ALKANES,

CYCLOPENTASILOXANE,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 POLYDIMETHYLSILOXYETHYL DIMETHICONE,

CYCLOHEXASILOXANE,MAGNESIUM SULFATE,MICA,

POLYHYDROXYSTEARIC ACID,PHENOXYETHANOL,

TRIETHOXYSIMETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE,

CAPRYLYL GLYCOL,DIMETHICONE/PEG-10/15 CROSSPOLYMER,

ETHYLHEXYLGLYCERIN,HEXYLENE GLYCOL,DIPOTASSIUM GLYCYRRHIZATE,

PERFLUORODECALIN,ZINC PCA,SACCHAROMYCES LYSATE EXTRACT,

CENTELLA ASIATICA EXTRACT,LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE,

OLEA EUROPAEA (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,

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 Ingredient

Titanium Dioxide 5.8 %

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 suncreen with a broad spectrum SPF valu of 15 or higer and other sun protection

measures including

limit time in the sun,especially from 10 am -2 pm

wear long sleeved shirts, pants,hats and sunglassess

Other information

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


Advanced Ingredient Data


Raw Label Data

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