SPL v1
SPL
SPL Set ID 3f81215c-e929-02cc-e063-6394a90a1b2b
Route
CUTANEOUS
Published
Effective Date 2025-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (8 g)
Inactive Ingredients
Aqua Niacinamide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-24

Description

Titanium Dioxide 8%

Purpose

sunscreen

Dosage and Administration

Stop use and ask a doctor if- Redness develops.

Contraindications

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


Medication Information

Purpose

sunscreen

Dosage and Administration

Stop use and ask a doctor if- Redness develops.

Contraindications

Keep out of reach of children.



If swallowed, get medical help or contact a Poison Control Center right away.

Description

Titanium Dioxide 8%

Uses

Helps prevent sunburn

Warnings

For external use only.



When using this product:

- Do not get into eyes. Rinse with water to remove.



Stop use and ask a doctor if:

- Rash occurs.



Keep out of reach of children.



If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use If You:

Do not use

- On damaged or broken skin.

- If you have known allergies to any ingredient in the product.

Inactive Ingredients

Aqua,Cyclopentasiloxane,Propylene Glycol,Glycerin,Lauryl PEG-9 PolydimethylsiloxyethylDimethicone,Ethylhexyl Salicylate,Cyclohexasiloxane,lsohexadecane,Polymethylsilsesquioxane,Hydrogenated Polyisobutene,Propylene Glycol Dicaprylate/Dicaprate,lron Oxides,Cetyl PEG/PPG-10/1Dimethicone,Polyglyceryl-4 lsostearate,Magnesium Sulfate,Tocopherol,Phenoxyethanol,Gentiana ScabraExtract,Methylparaben,Aroma,Propylparaben

Principal Display Panel

Stop Use and Ask A Doctor If:

Stop use and ask a doctor if

- Irritation or rash persists.

- Redness develops.

Active Ingredients (in Each Film)

Titanium Dioxide 8%

When Using This Product You May Experience:

Do not get into eyes. Rinse with water to remove


Structured Label Content

Uses

Helps prevent sunburn

Purpose

sunscreen

Warnings

For external use only.



When using this product:

- Do not get into eyes. Rinse with water to remove.



Stop use and ask a doctor if:

- Rash occurs.



Keep out of reach of children.



If swallowed, get medical help or contact a Poison Control Center right away.

Contraindications

Keep out of reach of children.



If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use If You: (Do not use if you:)

Do not use

- On damaged or broken skin.

- If you have known allergies to any ingredient in the product.

Inactive Ingredients (Inactive ingredients)

Aqua,Cyclopentasiloxane,Propylene Glycol,Glycerin,Lauryl PEG-9 PolydimethylsiloxyethylDimethicone,Ethylhexyl Salicylate,Cyclohexasiloxane,lsohexadecane,Polymethylsilsesquioxane,Hydrogenated Polyisobutene,Propylene Glycol Dicaprylate/Dicaprate,lron Oxides,Cetyl PEG/PPG-10/1Dimethicone,Polyglyceryl-4 lsostearate,Magnesium Sulfate,Tocopherol,Phenoxyethanol,Gentiana ScabraExtract,Methylparaben,Aroma,Propylparaben

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Dosage and Administration (Dosage and administration)

Stop use and ask a doctor if- Redness develops.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

Stop use and ask a doctor if

- Irritation or rash persists.

- Redness develops.

Active Ingredients (in Each Film) (Active ingredients (in each film))

Titanium Dioxide 8%

When Using This Product You May Experience: (When using this product you may experience:)

Do not get into eyes. Rinse with water to remove


Advanced Ingredient Data


Raw Label Data

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