SPL v2
SPL
SPL Set ID 23a55301-2277-6e4f-e063-6394a90af171
Route
TOPICAL
Published
Effective Date 2023-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-31
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 chance of skin

cancer and early skin aging caused by exposure to the sun.

Dosage and Administration

■ Apply liberally to cleansed neck & chest. Begin by massaging along the entire upper chest area in gentle, circular motions, moving

up the front & back of the neck. Apply in the morning for optimal results

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

Section 55106-9

Titanium Dioxide 4.2%

Section 60561-8

■ Protect the product in this container from excessive heat and direct sun.

Structured Label Content

Indications and Usage (34067-9)

■ Helps prevent sunburn. ■ If used as directed with other sun protection measures (see Directions), decreases the chance of skin

cancer and early skin aging caused by exposure to the sun.

Dosage and Administration (34068-7)

■ Apply liberally to cleansed neck & chest. Begin by massaging along the entire upper chest area in gentle, circular motions, moving

up the front & back of the neck. Apply in the morning for optimal results

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)

Section 55106-9 (55106-9)

Titanium Dioxide 4.2%

Section 60561-8 (60561-8)

■ Protect the product in this container from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:56.734429 · Updated: 2026-03-14T23:13:27.116919