FDA.reportPublic FDA data

iBlanc Restora-Bright Elite Natural Sun Defense

Product NDC
52960-201
11-digit product format
529600201
Labeler code
52960
Product ID
52960-201_d21fa970-c7f7-4f19-af10-15beec658272
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
iBlanc, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-09-23
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
14 g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52960-201-122019-11-27C16284748780-19855d018-e741-cd31-e053-dbdaa90ab51a1d7f1ddb-108f-49f4-baf4-5a457ff5e08e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52960-201-12iBlanc Restora-Bright Elite Natural Sun DefenseSPF 3045 g in 1 TUBELOTION453

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
ALEURITES MOLUCCANA SEEDINACTIVE INGREDIENTJ87WJ3E7VWIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
BARLEYINACTIVE INGREDIENT5PWM7YLI7RIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESINACTIVE INGREDIENTU72Q2I8C85IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
DOCOSANOLINACTIVE INGREDIENT9G1OE216XYIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
ERGOTHIONEINEINACTIVE INGREDIENTBDZ3DQM98WIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
ETHYL MACADAMIATEINACTIVE INGREDIENTANA2NCS6V1IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
GLYCERYL ISOSTEARATEINACTIVE INGREDIENTHYE7O27HAOIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKINACTIVE INGREDIENTT7S323PKJSIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
HYDROGENATED PALM GLYCERIDESINACTIVE INGREDIENTYCZ8EM144QIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
HYDROLYZED JOJOBA ESTERS (ACID FORM)INACTIVE INGREDIENTUDR641JW8WIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORNINACTIVE INGREDIENT9F8ET54T05IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
ISODECYL NEOPENTANOATEINACTIVE INGREDIENTW60VYE24XCIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
LONICERA CAPRIFOLIUM FLOWERINACTIVE INGREDIENT5N1WD9784UIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
LONICERA JAPONICA FLOWERINACTIVE INGREDIENT4465L2WS4YIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
MACADAMIA OILINACTIVE INGREDIENT515610SU8CIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
MALIC ACID, L-INACTIVE INGREDIENTJ3TZF807X5IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
PHELLODENDRON AMURENSE BARKINACTIVE INGREDIENTPBG27B754GIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
PHYTIC ACIDINACTIVE INGREDIENT7IGF0S7R8IIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
POLYGLYCERYL-10 STEARATEINACTIVE INGREDIENT90TF85HH91IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
PORPHYRA UMBILICALISINACTIVE INGREDIENT14AN0J70WOIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
RICE BRAN OILINACTIVE INGREDIENTLZO6K1506AIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
SANDALWOODINACTIVE INGREDIENT3641YW25N2IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
SODIUM STEAROYL LACTYLATEINACTIVE INGREDIENTIN99IT31LNIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RIBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52960-201IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]3Legacy NDC, 1 package rows20121027_1d7f1ddb-108f-49f4-baf4-5a457ff5e08e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52960-201-125296002011245 g in 1 TUBE45 gHistorical