FDA.reportPublic FDA data

Tinted Replenishing Daily Protection

Manufacturer
HELTON SKIN & LASER INSTITUTE | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:23:16

Label at a glance#

ProductTinted Replenishing Daily Protection
Active ingredientZINC OXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385679208507GTIN-13: 0385679208507
EAN-13: 0385679208507
GTIN-12: 385679208507
UPC-A: 385679208507
GTIN storage (14 digits): 00385679208507		Helton 208.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85679-208-50Tinted Replenishing Daily Protection50 g in 1 BOTTLE, PUMPCREAM502

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85679-20885679-208-50
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
NameUNIIKind
CERAMIDE 34370DF050BIACT
CI 77492EX438O2MRTIACT
CI 77499XM0M87F357IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
ZINC OXIDESOI2LOH54ZACTIB
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CYCLOHEXASILOXANEXHK3U310BAIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
CI 774911K09F3G675IACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Replenishing Daily ProtectionZINC OXIDEHELTON SKIN & LASER INSTITUTE35a9d07d-70e5-5eed-e063-6394a90aebaf2025-12-15Exact identifier
ndc (package): 85679-208-50
ndc (product): 85679-208
ndc11 (package): 85679020850
spl id: 4600ca1a-bf57-40de-e063-6394a90af359
spl set id: 35a9d07d-70e5-5eed-e063-6394a90aebaf
Proceuticals Private Label by TiZO tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd1cbcf8a6-0e83-f759-e063-6394a90ac14d2024-07-08WarningsExact identifier
ndc (product): 58892-208

Reported adverse events (FAERS/openFDA)#

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