FDA.reportPublic FDA data

Prime and Protect

Manufacturer
Shannon Cornelsen-Lewandowski | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:26:08

Label at a glance#

ProductPrime and Protect
Active ingredientTITANIUM DIOXIDE, ZINC 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-130385557203501GTIN-13: 0385557203501
EAN-13: 0385557203501
GTIN-12: 385557203501
UPC-A: 385557203501
GTIN storage (14 digits): 00385557203501		BLEND 203.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85557-203-50Prime and Protect53 g in 1 BOTTLE, PUMPCREAM532

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
85557-20385557-203-50
58892-203

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CI 77499XM0M87F357IACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
CI 77492EX438O2MRTIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
ALUMINALMI26O6933IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE92RU3N3Y1OIACT
CI 774911K09F3G675IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski36480f7f-37e8-decd-e063-6394a90ada602025-12-17Exact identifier
ndc (package): 85557-203-50
ndc (product): 85557-203
ndc11 (package): 85557020350
spl id: 46278184-553b-d003-e063-6394a90a8ce2
spl set id: 36480f7f-37e8-decd-e063-6394a90ada60
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski364827bd-5781-eb53-e063-6394a90ab22f2025-12-17Exact identifier
ndc (product): 85557-203
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD0b62062d-b77e-4e6c-b3ab-b35ab24db7cb2024-06-04WarningsExact identifier
ndc (product): 58892-203

Reported adverse events (FAERS/openFDA)#

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