Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8f9b2c24-21ee-43fd-a0e0-0cb1d0391400
Route
CUTANEOUS
Published
Effective Date 2011-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (2.79 g) Zinc Cation (0.59 g)
Inactive Ingredients
Talc Mica Silicon Dioxide Aluminum Starch Octenylsuccinate Dimethicone Octinoxate Triethoxycaprylylsilane Orange Aluminum Hydroxide Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-03-01
Description

Active ingredients: TITANIUM DIOXIDE 13.937%, ZINC OXIDE 2.94%

Medication Information

Warnings and Precautions

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation appear.

Indications and Usage

Indication and usage: Using the enclosed puff, apply evenly onto the entire face.

Dosage and Administration

Dosage and administration:

Give a smooth tapping massage around your skin with the enclosed puff, and reapply to areas which produce sebum secretion as often as possible to give a fresh finish.

Description

Active ingredients: TITANIUM DIOXIDE 13.937%, ZINC OXIDE 2.94%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

Talc, Mica (CI 77019), Silica, Aluminum Starch Octenylsuccinate, Dimethicone, Ethylhexyl Methoxycinnamate, Methicone, Iron Oxides (CI 77492), Triethoxycaprylylsilane, Citrus Aurantium Dulcis (Orange) Peel Oil, Iron Oxides (CI 77491), Aluminum Hydroxide, Methylparaben, Iron Oxides (CI 77499), Propylparaben

Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active ingredients: TITANIUM DIOXIDE 13.937%, ZINC OXIDE 2.94%

Structured Label Content

Indications and Usage (34067-9)

Indication and usage: Using the enclosed puff, apply evenly onto the entire face.

Dosage and Administration (34068-7)

Dosage and administration:

Give a smooth tapping massage around your skin with the enclosed puff, and reapply to areas which produce sebum secretion as often as possible to give a fresh finish.

Warnings and Precautions (34071-1)

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation appear.

Section 50565-1 (50565-1)

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients:

Talc, Mica (CI 77019), Silica, Aluminum Starch Octenylsuccinate, Dimethicone, Ethylhexyl Methoxycinnamate, Methicone, Iron Oxides (CI 77492), Triethoxycaprylylsilane, Citrus Aurantium Dulcis (Orange) Peel Oil, Iron Oxides (CI 77491), Aluminum Hydroxide, Methylparaben, Iron Oxides (CI 77499), Propylparaben

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Protects skin from UV rays.

Section 55106-9 (55106-9)

Active ingredients: TITANIUM DIOXIDE 13.937%, ZINC OXIDE 2.94%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:21.039209 · Updated: 2026-03-14T22:52:53.430326