FDA.reportPublic FDA data

No Makeup Bronzer SPF15

Manufacturer
N.V Perricone LLC | Dimensional Merchandising Inc (DMI)
Effective date
2023-07-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:55:31

Label at a glance#

ProductNo Makeup Bronzer SPF15
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

DosageDosage

OTC - ACTIVE INGREDIENT SECTION

ActivesActives

INACTIVE INGREDIENT SECTION

InactivesInactives

INDICATIONS & USAGE SECTION

IndicationsIndications

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

ChildrenChildren

OTC - PURPOSE SECTION

PurposePurpose

OTHER SAFETY INFORMATION

Base LabelBase Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45634-711-032025-01-30C16284748780-12cef2736-6a25-d83d-e063-dadaa90ab31fde1de12b-7c09-dd58-e053-2a95a90a6390

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45634-711-03No Makeup Bronzer SPF1513.9 g in 1 BOTTLE, WITH APPLICATORLIQUID13.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45634-711NO MAKEUP BRONZER SPF15 (ZINC OXIDE) LIQUID [N.V PERRICONE LLC]2Legacy NDC, 1 package rows20230711_de1de12b-7c09-dd58-e053-2a95a90a6390.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45634-71145634-711-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
QUATERNIUM-90 BENTONITE97K5YEF88CIACT
ISODODECANEA8289P68Y2IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM CHLORIDE451W47IQ8XIACT
ETHYL FERULATE5B8915UELWIACT
PROPYLENE CARBONATE8D08K3S51EIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
FERROUS OXIDEG7036X8B5HIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
DIPROPYLENE GLYCOLE107L85C40IACT
SODIUM CITRATE1Q73Q2JULRIACT
XYLITOLVCQ006KQ1EIACT
CAPRYLIC ACIDOBL58JN025IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
DIMETHICONE92RU3N3Y1OIACT
ZINC OXIDESOI2LOH54ZACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
MICAV8A1AW0880IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MALTODEXTRIN7CVR7L4A2DIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ALPINIA OFFICINARUM LEAF8584IDD6ORIACT
TOCOPHEROLR0ZB2556P8IACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
00232275-64d4-9d37-e063-6294a90a1acbde1de12b-7c09-dd58-e053-2a95a90a63902023-07-10Exact identifier
spl id: 00232275-64d4-9d37-e063-6294a90a1acb
spl set id: de1de12b-7c09-dd58-e053-2a95a90a6390

Reported adverse events (FAERS/openFDA)#

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