SPL v1
SPL
SPL Set ID dd16499a-1711-5855-e053-2a95a90affae
Route
TOPICAL
Published
Effective Date 2022-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.315 g)
Inactive Ingredients
Isopropyl Titanium Triisostearate Sorbitan Isostearate Butylene Glycol Pentylene Glycol D&c Red No. 28 Palmitoyl Tripeptide-1 Ferrous Oxide Polyglyceryl-2 Diisostearate Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer High Density Polyethylene Simmondsia Chinensis Seed Bis-peg-10 Dimethicone/dimer Dilinoleate Copolymer Vinylpyrrolidone/eicosene Copolymer Ethylhexyl Palmitate Silica Dimethyl Silylate Glyceryl Isostearate Alpha-tocopherol Acetate Argania Spinosa Seed .alpha.-bisabolol, (+)- Synthetic Wax (1800 Mw) Peg-8 Beeswax C10-30 Cholesterol/lanosterol Esters Methacrylate/methoxy Peg-10 Maleate/styrene Copolymer Acrylic Acid/ethylene Copolymer (600 Mpa.s) Vanillin Polyhydroxystearic Acid (2300 Mw) D&c Red No. 6 Octyldodecanol Butylated Hydroxytoluene Tridecyl Trimellitate Hydrogenated Jojoba Oil Ceresin Crambe Hispanica Subsp. Abyssinica Seed Oil Isostearic Acid Tribehenin

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-04-20


Medication Information

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Section 55106-9

Section 60561-8


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)

Section 60561-8 (60561-8)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)