SPL v2
SPL
SPL Set ID 2fc6e168-b2c1-bf9d-e063-6394a90aade7
Route
TOPICAL
Published
Effective Date 2024-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (100 mg) Zinc Oxide (30 mg)
Inactive Ingredients
Mica Triethanolamine Bismuth Oxychloride Caprylic/capric Triglyceride Cyclopentasiloxane Isohexadecane Caprylhydroxamic Acid Ceteareth-20 Dimethicone Ethylhexyl Hydroxystearate Benzoate Ci 77491 Edetate Disodium Anhydrous Isododecane Melissa Officinalis Peg-30 Dipolyhydroxystearate Triethoxycaprylylsilane Glycerin Water Tocopherol Caprylyl Glycol Octyldodecyl Neopentanoate Tetrahexyldecyl Ascorbate Microcrystalline Wax Sodium Chloride Alpha-tocopherol Acetate Cyclohexasiloxane Ci 77499 Ci 77492

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-24

Description

Titanium Dioxide 10% Zinc Oxide 3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 10% Zinc Oxide 3%

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.

Section 51945-4

Purpose:

Sunscreen

Warning:

Keep out of the reach of children

Warnings:

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medicalhelp 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 • Children under 6 months: Ask a doctor • 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 am-2 pm • Wear long-sleeved shirts, pants, hats, and sunglasses

Other Information:

• Protect this product from excessive heat and direct sun • May stain some fabrics

Active Ingredients:

Titanium Dioxide 10%

Zinc Oxide 3%

Inactive Ingredients:

Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water


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.

Section 51945-4 (51945-4)

Purpose:

Sunscreen

Warning:

Keep out of the reach of children

Warnings:

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medicalhelp 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 • Children under 6 months: Ask a doctor • 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 am-2 pm • Wear long-sleeved shirts, pants, hats, and sunglasses

Other Information:

• Protect this product from excessive heat and direct sun • May stain some fabrics

Active Ingredients:

Titanium Dioxide 10%

Zinc Oxide 3%

Inactive Ingredients:

Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water


Advanced Ingredient Data


Raw Label Data

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