SPL v6
SPL
SPL Set ID dfc358a3-c946-bdf2-e053-2995a90aaad9
Route
TOPICAL
Published
Effective Date 2022-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.7434 g)
Inactive Ingredients
Mica Albizia Julibrissin Bark Titanium Dioxide Triceteareth-4 Phosphate Polyglyceryl-6 Polyricinoleate Xanthan Gum Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Dimethicone/peg-10/15 Crosspolymer .alpha.-tocopherol Acetate Triheptanoin Tribehenin Magnesium Potassium Aluminosilicate Fluoride C13-16 Isoparaffin Sodium Chloride Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Dipropylene Glycol Glycerin Argan Oil Triethoxycaprylylsilane Silicon Dioxide Ethylhexylglycerin Stannous Oxide Sodium Benzoate Superoxide Dismutase (saccharomyces Cerevisiae) Sodium Citrate Darutoside Tocopherol Water Dimethicone Cyclomethicone 5 Butyloctyl Salicylate Butylene Glycol Nylon-12 Phenoxyethanol Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Levomenol Edetate Disodium Anhydrous Octyldodecanol Potassium Sorbate Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-04-26


Medication Information

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Section 55106-9


Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)