SPL v2
SPL
SPL Set ID 23f4cf41-0eed-2df3-e063-6294a90ad402
Route
TOPICAL
Published
Effective Date 2018-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.2 g)
Inactive Ingredients
Xanthan Gum Hydrogenated Soybean Phosphatidylcholine Thioctic Acid Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Hydrogenated Soybean Lecithin Mannitol Dimethicone Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Polysorbate 60 Water Cyclomethicone 5 Ethylhexyl Methoxycrylene Tetrahexyldecyl Ascorbate Sorbitan Isostearate Diethylhexyl Syringylidenemalonate Isohexadecane Stearic Acid Glycerin Niacinamide Pentylene Glycol Benzyl Alcohol Aluminum Hydroxide Levomenol Phenoxyethanol Medium-chain Triglycerides Acetyl Tetrapeptide-9 Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Potassium Sorbate Sodium Benzoate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-01-29
Description

Titanium Dioxide 4.2%

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

For Sunscreen Use: ■ Apply liberally 15 minutes before sun exposure. ■ Use a water resistant sunscreen if swimming or sweating. ■ Reapply at least every 2 hours. ■ Not for use on children.

■ 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

Titanium Dioxide 4.2%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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, Dimethicone, Cyclopentasiloxane, Glycerin, Ethylhexyl Methoxycrylene, Niacinamide, Pentylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyester-8, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Benzyl Alcohol, Aluminum Hydroxide, Stearic Acid, Isohexadecane, Diethylhexyl Syringylidenemalonate, Hydrogenated Lecithin, Polysilicone-11, Mannitol, Bisabolol, Polysorbate 60, Tetrahexyldecyl Ascorbate, Sorbitan Isostearate, Phenoxyethanol, Caprylic/Capric Triglyceride, Potassium Sorbate, Sodium Benzoate, Xanthan Gum, Hydrogenated Phosphatidylcholine, Thioctic Acid, Acetyl Tetrapeptide-9

Section 51945-4

Section 53413-1

1-888-823-7837

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 4.2%

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)

For Sunscreen Use: ■ Apply liberally 15 minutes before sun exposure. ■ Use a water resistant sunscreen if swimming or sweating. ■ Reapply at least every 2 hours. ■ Not for use on children.

■ 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)

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 immediately.

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, Dimethicone, Cyclopentasiloxane, Glycerin, Ethylhexyl Methoxycrylene, Niacinamide, Pentylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyester-8, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Benzyl Alcohol, Aluminum Hydroxide, Stearic Acid, Isohexadecane, Diethylhexyl Syringylidenemalonate, Hydrogenated Lecithin, Polysilicone-11, Mannitol, Bisabolol, Polysorbate 60, Tetrahexyldecyl Ascorbate, Sorbitan Isostearate, Phenoxyethanol, Caprylic/Capric Triglyceride, Potassium Sorbate, Sodium Benzoate, Xanthan Gum, Hydrogenated Phosphatidylcholine, Thioctic Acid, Acetyl Tetrapeptide-9

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-888-823-7837

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 4.2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:51.076825 · Updated: 2026-03-14T23:13:16.476899