SPL v1
SPL
SPL Set ID 00243a6d-a409-3e63-e063-6294a90a5459
Route
TOPICAL
Published
Effective Date 2022-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.48 g)
Inactive Ingredients
Levomenol Phenoxyethanol Polysorbate 60 Hydrogenated Soybean Lecithin Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Xanthan Gum Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Pentylene Glycol Benzyl Alcohol Stearic Acid Aluminum Hydroxide Isohexadecane Thioctic Acid Phospholipase D1 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

Identifiers & Packaging

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


Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 54433-8

Section 55105-1

Section 55106-9


Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 54433-8 (54433-8)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)