SPL v2
SPL
SPL Set ID 316ea01b-4bff-55be-e063-6394a90add94
Route
TOPICAL
Published
Effective Date 2025-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ci 77947 (1.5 g) Titanium Dioxide
Inactive Ingredients
Camellia Sinensis Leaf Tetrahexyldecyl Ascorbate Butylene Glycol Sodium Chloride Lysine Ferrosoferric Oxide Retinyl Palmitate Sodium Hyaluronate Cyclopentasiloxane Matricaria Chamomilla Boron Nitride Stearic Acid Dextrin Palmitate (corn; 20000 Mw) Panax Ginseng Root Oil Triethoxycaprylylsilane Magnesium Ascorbyl Phosphate Sodium Dehydroacetate Tocopherol Methicone (20 Cst) Aluminum Hydroxide Glycerin Octyldodecyl Neopentanoate Potassium Sorbate Palmitic Acid Water Ferric Oxide Yellow Potassium Chloride Zinc Chloride Peg/ppg-18/18 Dimethicone Magnesium Chloride Dimethicone Mica Ferric Oxide Red Hexylene Glycol Phenoxyethanol Edetate Disodium Ginkgo Biloba Leaf Oil Phytantriol Caprylyl Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01
Description

Titanium Dioxide 5% Zinc Oxide 5%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

■ 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

■ apply smoothly on cleansed skin

■ apply liberally 15 minutes before sun exposure

■ use a water-resistant sunscreen if swimming or sweating

■ reapply at least every 2 hours

■ children under 6 months of age: 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 a.m. – 2 p.m.

■ wear long-sleeve shirts, pants, hats, and sunglasses

Description

Titanium Dioxide 5% Zinc Oxide 5%

Section 34092-7

■ for normal to oily skin

■ dermatologist tested

■ may stain some fabrics

Section 44425-7

■ protect this product from excessive heat and direct sun

■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Section 50565-1

Keep out of reach of children.

If product is 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), cyclopentasiloxane, butylene glycol, octyldodecyl neopentanoate, PEG/PPG-18/18 dimethicone, dimethicone, magnesium chloride, potassium chloride, sodium chloride, zinc chloride, lysine, tocopherol, tetrahexyldecyl ascorbate, magnesium ascorbyl phosphate, retinyl palmitate, panax ginseng root extract, ginkgo biloba leaf extract, camellia sinensis leaf extract, chamomilla recutita (matricaria) flower extract, octyldodecanol, sodium hyaluronate, phytantriol, glycerin, triethoxycaprylylsilane, boron nitride, dextrin palmitate, palmitic acid, methicone, stearic acid, aluminum hydroxide, hexylene glycol, disodium EDTA, potassium sorbate, sodium dehydroacetate, caprylyl glycol, phenoxyethanol, (+/-): iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891), mica

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 5%

Zinc Oxide 5%

Structured Label Content

Indications and Usage (34067-9)

■ 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)

■ apply smoothly on cleansed skin

■ apply liberally 15 minutes before sun exposure

■ use a water-resistant sunscreen if swimming or sweating

■ reapply at least every 2 hours

■ children under 6 months of age: 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 a.m. – 2 p.m.

■ wear long-sleeve shirts, pants, hats, and sunglasses

Warnings and Precautions (34071-1)

For external use only

Section 34092-7 (34092-7)

■ for normal to oily skin

■ dermatologist tested

■ may stain some fabrics

Section 44425-7 (44425-7)

■ protect this product from excessive heat and direct sun

■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Section 50565-1 (50565-1)

Keep out of reach of children.

If product is 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), cyclopentasiloxane, butylene glycol, octyldodecyl neopentanoate, PEG/PPG-18/18 dimethicone, dimethicone, magnesium chloride, potassium chloride, sodium chloride, zinc chloride, lysine, tocopherol, tetrahexyldecyl ascorbate, magnesium ascorbyl phosphate, retinyl palmitate, panax ginseng root extract, ginkgo biloba leaf extract, camellia sinensis leaf extract, chamomilla recutita (matricaria) flower extract, octyldodecanol, sodium hyaluronate, phytantriol, glycerin, triethoxycaprylylsilane, boron nitride, dextrin palmitate, palmitic acid, methicone, stearic acid, aluminum hydroxide, hexylene glycol, disodium EDTA, potassium sorbate, sodium dehydroacetate, caprylyl glycol, phenoxyethanol, (+/-): iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891), mica

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 5%

Zinc Oxide 5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:48.465222 · Updated: 2026-03-14T23:08:08.103878