dc876b06-bc4e-3a00-e053-2a95a90afa6e

SPL v2

SPL

SPL Set ID dc876b06-bc4e-3a00-e053-2a95a90afa6e

Route

topical

Published

Effective Date 2022-05-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

zinc oxide (2.478 g)

Inactive Ingredients

titanium dioxide tocopherol sodium phosphate, dibasic, anhydrous ferrous oxide acrylic acid/2-ethylhexyl acrylate/styrene copolymer (500000 mw) propylene carbonate edetate disodium anhydrous c13-16 isoparaffin mannitol silicon dioxide acetyl tetrapeptide-9 palmitoyl tripeptide-1 butylene glycol peg-9 polydimethylsiloxyethyl dimethicone alkyl (c12-15) benzoate isododecane caprylyl glycol triethoxycaprylylsilane ethyl glycolate butyloctyl salicylate triheptanoin c18-36 acid triglyceride dimethicone/peg-10/15 crosspolymer dimethicone alcohol palmitoyl tetrapeptide-7 dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) water glycerin bellis perennis hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer quaternium-90 bentonite alpha-tocopherol acetate sodium chloride potassium sorbate triceteareth-4 phosphate cetyl peg/ppg-10/1 dimethicone (hlb 2) polyglyceryl-3 diisostearate argan oil polyglyceryl-6 polyricinoleate xanthan gum phenoxyethanol dimethicone/vinyl dimethicone crosspolymer (soft particle) sorbitan monolaurate octyldodecanol levomenol hexylene glycol dipropylene glycol phenylethyl alcohol sodium citrate potassium chloride potassium phosphate, dibasic

Identifiers & Packaging

Pill Appearance

Color: white Color: brown

Marketing Status

otc monograph final active Since 2022-04-13

Medication Information

Active Ingredient

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

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)

Advanced Ingredient Data

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Source: dailymed · Ingested: 2026-02-15T12:01:02.192155 · Updated: 2026-03-14T23:01:14.422395