208

Manufacturer: PETER L. KOPELSON, M.D., | Custom Analytics LLC | Fragrance Manufacturing INC | Fallien Cosmeceuticals Ltd.
Effective date: 2025-12-11
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:21:54

Label at a glance#

Product208

Active ingredientZINC OXIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85443-208-50	208	53 g in 1 BOTTLE, PUMP	CREAM	53		2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

208
Zinc Oxide
CI 77491
DIMETHICONE CROSSPOLYMER
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
HYDROGEN DIMETHICONE (20 CST)
PEG-10 DIMETHICONE (600 CST)
CAPRYLIC/CAPRIC TRIGLYCERIDE
CERAMIDE 3
CI 77499
ALPHA-TOCOPHEROL ACETATE
DIMETHICONE
POLYHYDROXYSTEARIC ACID (2300 MW)
TETRAHEXYLDECYL ASCORBATE
CI 77492
CYCLOHEXASILOXANE
DIMETHICONOL (2000 CST)
CYCLOPENTASILOXANE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85443-208	85443-208-50
58892-208

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CI 77491	1K09F3G675	IACT
DIMETHICONE CROSSPOLYMER	UF7620L1W6	IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)	9E4CO0W6C5	IACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER	9NH1UDD2RR	IACT
HYDROGEN DIMETHICONE (20 CST)	12Z59IF64N	IACT
PEG-10 DIMETHICONE (600 CST)	8PR7V1SVM0	IACT
CAPRYLIC/CAPRIC TRIGLYCERIDE	C9H2L21V7U	IACT
CERAMIDE 3	4370DF050B	IACT
CI 77499	XM0M87F357	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
DIMETHICONE	92RU3N3Y1O	IACT
POLYHYDROXYSTEARIC ACID (2300 MW)	YXH47AOU0F	IACT
TETRAHEXYLDECYL ASCORBATE	9LBV3F07AZ	IACT
CI 77492	EX438O2MRT	IACT
CYCLOHEXASILOXANE	XHK3U310BA	IACT
DIMETHICONOL (2000 CST)	T74O12AN6Y	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB
CYCLOPENTASILOXANE	0THT5PCI0R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
208	ZINC OXIDE	PETER L. KOPELSON, M.D.	351ce033-6bd0-574e-e063-6394a90af448	2025-12-11		Exact identifier ndc (product): 85443-208
208	ZINC OXIDE	PETER L. KOPELSON, M.D.,	351c9727-d7ac-9c3f-e063-6294a90a7721	2025-12-11		Exact identifier ndc (package): 85443-208-50 ndc (product): 85443-208 ndc11 (package): 85443020850 spl id: 45b4544b-2c3b-fbcc-e063-6394a90a2240 spl set id: 351c9727-d7ac-9c3f-e063-6294a90a7721
Proceuticals Private Label by TiZO tinted replenishing daily protection	ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1cbcf8a6-0e83-f759-e063-6394a90ac14d	2024-07-08	Warnings	Exact identifier ndc (product): 58892-208

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.