SPL v7
SPL
SPL Set ID df6f642d-0f5b-df38-e053-2995a90ad78c
Route
TOPICAL
Published
Effective Date 2022-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (2.478 g)
Inactive Ingredients
Octyldodecanol Glycerin Heptyl Undecylenate Polysorbate 60 Hydrated Silica Edetate Disodium Anhydrous Carbomer Homopolymer, Unspecified Type Phenylethyl Alcohol Bellis Perennis Water Isohexadecane Phenoxyethanol Caprylyl Glycol Cetyl Alcohol Xanthan Gum Sodium Phosphate, Dibasic, Anhydrous Potassium Chloride Potassium Phosphate, Unspecified Form Palmitoyl Tripeptide-1 Ferrous Oxide Triethoxycaprylylsilane Potassium Sorbate Butylene Glycol Palmitoyl Tetrapeptide-7 Sodium Chloride Citric Acid Monohydrate Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Butyloctyl Salicylate Peg-10 Stearate Polysorbate 20 Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Hexylene Glycol Glyceryl Stearate/peg-100 Stearate Sorbitan Isostearate

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-04-29


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)