Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 819546f1-8ec3-43e3-8ecb-d89e08cc9dff
Route
TOPICAL
Published
Effective Date 2022-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (12 g)
Inactive Ingredients
Water C12-15 Alcohols Caprylic/capric Acid Propanediol Jojoba Acid Methylheptyl Isostearate Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Nylon-12 Niacinamide Methylpropanediol Coco-caprylate Silicon Dioxide Polyglyceryl-2 Dipolyhydroxystearate Sodium Chloride Oryza Sativa Whole Helianthus Annuus Whole Bisabolol Oxide A Allantoin Lecithin, Soybean Caprylyl Glycol Glycerin Tocopherol Camellia Sinensis Seed Rosmarinus Officinalis Flower Tetrasodium Glutamate Diacetate Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-02-22

Description

Zinc Oxide 12%


Medication Information

Description

Zinc Oxide 12%

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

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a docor if rash occurs

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

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

• after 40 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 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-sleeve shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Zinc Oxide 12%

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Propanediol, Jojoba Esters, Methylheptyl Isostearate, Tridecyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Nylon-12, Niacinamide, Methylpropanediol, Coco-Caprylate, Silica, Sodium Chloride, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Lecithin, Phenylpropanol, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide

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Structured Label Content

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

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a docor if rash occurs

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

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

• after 40 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 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-sleeve shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Zinc Oxide 12%

Inactive Ingredients (Inactive ingredients)

Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Propanediol, Jojoba Esters, Methylheptyl Isostearate, Tridecyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Nylon-12, Niacinamide, Methylpropanediol, Coco-Caprylate, Silica, Sodium Chloride, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Lecithin, Phenylpropanol, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide

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Advanced Ingredient Data


Raw Label Data

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