FDA.reportPublic FDA data

Prime Protection Sunscreen non tinted

Manufacturer
KRISTI REDD ESTHETICS | Custom Analytics LLC | Fragrance Manufacturing INC | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:22:44

Label at a glance#

ProductPrime Protection Sunscreen non tinted
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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-130385641202502GTIN-13: 0385641202502
EAN-13: 0385641202502
GTIN-12: 385641202502
UPC-A: 385641202502
GTIN storage (14 digits): 00385641202502		redd 202.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85641-202-50Prime Protection Sunscreen non tinted53 g in 1 BOTTLE, PUMPCREAM532

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85641-20285641-202-50
58892-202

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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

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
Prime Protection Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS36608832-22d8-bc76-e063-6394a90abac62025-12-12Exact identifier
ndc (package): 85641-202-50
ndc (product): 85641-202
ndc11 (package): 85641020250
spl id: 45c7395f-5c91-d388-e063-6294a90a1e29
spl set id: 36608832-22d8-bc76-e063-6394a90abac6
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1ce8c1da-565d-5487-e063-6294a90a1bde2024-07-10WarningsExact identifier
ndc (product): 58892-202

Reported adverse events (FAERS/openFDA)#

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