Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 11fce5ec-66e8-9eac-e063-6394a90aaf3a
Route
TOPICAL
Published
Effective Date 2024-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (18.1 g)
Inactive Ingredients
Stearic Acid Polyhydroxystearic Acid (2300 Mw) Medium-chain Triglycerides Isohexadecane Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Polysorbate 60 Sorbitan Isostearate Palmitic Acid Tetrahexyldecyl Ascorbate Phenoxyethanol Acetyl Zingerone Hexylene Glycol Mannitol Vanilla Potassium Sorbate Tocopherol Water Dimethicone/peg-10/15 Crosspolymer Magnesium Sulfate Heptahydrate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Lecithin, Soybean Aloe Vera Leaf Haematococcus Pluvialis Phenylpropanol Sodium Benzoate Sodium Citrate Dicaprylyl Carbonate Hyaluronate Sodium Cyclomethicone 5 Dimethicone Glycerin Ethylhexylglycerin Methylpropanediol Panthenol Squalane Phosphatidylcholine Translocator Abcb4 Green Tea Leaf Ectoine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-22

Description

Active ingredients : Zinc Oxide 18.1%


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 • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours

• 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 ingredients : Zinc Oxide 18.1%

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

Water /Aqua/Eau, Cyclopentasiloxane, Dicaprylyl Carbonate, Polyhydroxystearic Acid, Dimethicone, Glycerin, Lecithin, Isohexadecane, Aloe Barbadensis Leaf Juice, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Magnesium Sulfate Heptahydrate, Acetyl Zingerone, Phenoxyethanol, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Phosphatidylcholine, Mannitol, Vanilla Planifolia Fruit Extract, Camellia Sinensis Leaf Extract, Methyl Propanediol, Sodium Hyaluronate, Polysorbate 60,Ectoin,Sodium Citrate,Sorbitan Isostearate, Tocopherol, Stearic Acid, Palmitic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Sodium Benzoate, Potassium Sorbate

Section 51945-4

Section 55105-1

Purpose:

Sunscreen

Section 55106-9

Active ingredients :

Zinc Oxide 18.1%

Section 60561-8

Other information • protect the product in this container from excessive heat and direct sun • Due to the presence of botanical ingredients , this product may change in color over time.


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 • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours

• 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)

Water /Aqua/Eau, Cyclopentasiloxane, Dicaprylyl Carbonate, Polyhydroxystearic Acid, Dimethicone, Glycerin, Lecithin, Isohexadecane, Aloe Barbadensis Leaf Juice, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Magnesium Sulfate Heptahydrate, Acetyl Zingerone, Phenoxyethanol, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Phosphatidylcholine, Mannitol, Vanilla Planifolia Fruit Extract, Camellia Sinensis Leaf Extract, Methyl Propanediol, Sodium Hyaluronate, Polysorbate 60,Ectoin,Sodium Citrate,Sorbitan Isostearate, Tocopherol, Stearic Acid, Palmitic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Sodium Benzoate, Potassium Sorbate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Sunscreen

Section 55106-9 (55106-9)

Active ingredients :

Zinc Oxide 18.1%

Section 60561-8 (60561-8)

Other information • protect the product in this container from excessive heat and direct sun • Due to the presence of botanical ingredients , this product may change in color over time.


Advanced Ingredient Data


Raw Label Data

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