dd16499a-1711-5855-e053-2a95a90affae

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

Active Ingredient

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Section 60561-8


Structured Label Content

Active Ingredient (55106-9)

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 60561-8 (60561-8)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)