SPL v2
SPL
SPL Set ID 397b4338-fec8-5228-e063-6394a90ad97d
Route
TOPICAL
Published
Effective Date 2022-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.2 g)
Inactive Ingredients
Phenoxyethanol Polysorbate 60 Hydrogenated Soybean Lecithin Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Xanthan Gum Cyclopentasiloxane Pentylene Glycol Benzyl Alcohol Stearic Acid Aluminum Hydroxide Isohexadecane Thioctic Acid Diethylhexyl Syringylidenemalonate Potassium Sorbate Medium-chain Triglycerides Haematococcus Pluvialis Tocopherol Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Tetrahexyldecyl Ascorbate Sorbitan Isostearate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Water Glycerin Ethylhexyl Methoxycrylene Bisabolol Hydrogenated Soybean Phosphatidylcholine Dimethicone Sodium Benzoate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-28
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

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

■ keep out of eyes. Rinse with water to remove.

Section 50570-1

■ on damaged or broken skin.

Section 51727-6

Water/Aqua/Eau, Glycerin, Cyclopentasiloxane, Dimethicone,

Pentylene Glycol, Ethylhexyl Methoxycrylene, Polyester-8,

Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone,

Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate

Copolymer, Benzyl Alcohol, Aluminum Hydroxide, Stearic

Acid, Diethylhexyl Syringylidenemalonate, Hydrogenated

Lecithin, Isohexadecane, Bisabolol, Polysilicone-11,

Phenoxyethanol, Tetrahexyldecyl Ascorbate, Polysorbate

60, Sorbitan Isostearate, Potassium Sorbate, Sodium

Benzoate, Caprylic/Capric Triglyceride, Xanthan Gum,

Hydrogenated Phosphatidylcholine, Thioctic Acid,

Haematococcus Pluvialis Extract, Tocopherol

Section 51945-4

Section 53413-1

1-888-823-7837

Section 55105-1

Sunscreen

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 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)

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)

■ keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

■ on damaged or broken skin.

Section 51727-6 (51727-6)

Water/Aqua/Eau, Glycerin, Cyclopentasiloxane, Dimethicone,

Pentylene Glycol, Ethylhexyl Methoxycrylene, Polyester-8,

Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone,

Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate

Copolymer, Benzyl Alcohol, Aluminum Hydroxide, Stearic

Acid, Diethylhexyl Syringylidenemalonate, Hydrogenated

Lecithin, Isohexadecane, Bisabolol, Polysilicone-11,

Phenoxyethanol, Tetrahexyldecyl Ascorbate, Polysorbate

60, Sorbitan Isostearate, Potassium Sorbate, Sodium

Benzoate, Caprylic/Capric Triglyceride, Xanthan Gum,

Hydrogenated Phosphatidylcholine, Thioctic Acid,

Haematococcus Pluvialis Extract, Tocopherol

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%

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

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Source: dailymed · Ingested: 2026-02-15T12:08:46.840302 · Updated: 2026-03-14T23:13:09.195902