SPL v2
SPL
SPL Set ID 38c80373-1d5a-c7f4-e063-6294a90aa9c2
Route
TOPICAL
Published
Effective Date 2022-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.2 g)
Inactive Ingredients
Dimethicone Bisabolol Glycerin Mica Ci 77491 Polysorbate 60 Ci 77499 Pegoterate Silica Dimethyl Silylate Xanthan Gum Tocopherol Citronellol Cyclopentasiloxane Pentylene Glycol Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Benzyl Alcohol Hydrogenated Soybean Lecithin Stearic Acid Hydrogenated Soybean Phosphatidylcholine Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Diethylhexyl Syringylidenemalonate Tetrahexyldecyl Ascorbate Potassium Sorbate Aluminum Hydroxide Sorbitan Isostearate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Thioctic Acid Sodium Benzoate Caprylic/capric Triglyceride Fragrance 13576 Haematococcus Pluvialis Geraniol Hydroxycitronellal Water Ethylhexyl Methoxycrylene Isohexadecane Ci 77492

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-17
Description

Titanium Dioxide 4.2%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

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.

Dosage and Administration

Directions

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, 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, Mica, Polysilicone-11, Polyester-1, Silica Dimethyl Silylate, Tetrahexyldecyl Ascorbate, Polysorbate 60, Sorbitan Isostearate, Caprylic/Capric Triglyceride, Fragrance (Parfum), Xanthan Gum, Hydrogenated Phosphatidylcholine, Potassium Sorbate, Sodium Benzoate, Thioctic Acid, Haematococcus Pluvialis Extract, Tocopherol, Citronellol, Geraniol, Hydroxycitronellal, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492, CI 77491, CI 77499).

Section 51945-4

Section 53413-1

1-888-823-7837

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 4.2%

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

Directions

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, 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, Mica, Polysilicone-11, Polyester-1, Silica Dimethyl Silylate, Tetrahexyldecyl Ascorbate, Polysorbate 60, Sorbitan Isostearate, Caprylic/Capric Triglyceride, Fragrance (Parfum), Xanthan Gum, Hydrogenated Phosphatidylcholine, Potassium Sorbate, Sodium Benzoate, Thioctic Acid, Haematococcus Pluvialis Extract, Tocopherol, Citronellol, Geraniol, Hydroxycitronellal, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492, CI 77491, CI 77499).

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)

Other information ■ 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: 2026-02-15T12:07:45.170702 · Updated: 2026-03-14T23:11:32.027299