iBlanc Restora-Bright Elite Natural Sun Defense

Manufacturer
iBlanc, Inc.
Effective date
2012-10-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:33:24

Label at a glance#

ProductiBlanc Restora-Bright Elite Natural Sun Defense SPF 30
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

13.5% ZINC OXIDE

OTC - PURPOSE SECTION

HELPS PREVENT SUNBURN

WARNINGS AND PRECAUTIONS SECTION

DO NOT USE ON DAMAGED OR BROKEN SKIN. KEEP OUT OF EYES.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: AQUA (WATER), CAPRYLIC/CAPRIC TRIGLYCERIDE, CANDELILLA/JOJOBA/RICE BRAN POLYGLYCERYL-3 ESTERS, GLYCERIN, ISODECYL NEOPENTANOATE, ETHYL MACADAMIATE, ALEURITES MOLUCCANA SEED OIL, HYDROXYPROPYL STARCH PHOSPHATE, GLYCERYL STEARATE, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER, ERGOTHIONEINE (L), HORDEUM DISTICHON (BARLEY) EXTRACT, MACADAMIA TERNIFOLIA SEED OIL, PORPHYRA UMBITICALIS (RED ALGAE) EXTRACT, SANTALUM ALBUM (SANDALWOOD) EXTRACT, PHELLODENDROM AMURENSE BARK EXTRACT, GLYCERYL ISOSTEARATE, SODIUM STEROYL LACTYLATE, POLYGLYCERYL-10 PENTASTEARATE, POLYHYDROXYSTEARIC ACID, TOCOPHEROL (D-ALPHA), TOCOPHERYL ACETATE (D-ALPHA), LECITHIN, MALIC ACID (L), LONICERA CAPRIFOLIUM (HONEYSUCKLE) FLOWER EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, POTASSIUM CETYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, ALCOHOL, CETEARYL ALCOHOL, BEHENYL ALCOHOL, HYDROXYPROPYL METHYLCELLULOSE, SODIUM LACTATE, PHYTIC ACID, CITRIC ACID, SODIUM HYDROXIDE.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advanced Sun Defense SPF30 ART 2012-08-01_LBLAdvanced Sun Defense SPF30 ART 2012-08-01_LBL

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS

CALL TOLL FREE 855-2-IBLANC

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 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z3
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z3
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4N3
ALCOHOLINACTIVE INGREDIENT3K9958V90M3
ALEURITES MOLUCCANA SEEDINACTIVE INGREDIENTJ87WJ3E7VW3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL3
BARLEYINACTIVE INGREDIENT5PWM7YLI7R3
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX193
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESINACTIVE INGREDIENTU72Q2I8C853
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S3
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY3
ERGOTHIONEINEINACTIVE INGREDIENTBDZ3DQM98W3
ETHYL MACADAMIATEINACTIVE INGREDIENTANA2NCS6V13
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
GLYCERYL ISOSTEARATEINACTIVE INGREDIENTHYE7O27HAO3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE43
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKINACTIVE INGREDIENTT7S323PKJS3
HYDROGENATED PALM GLYCERIDESINACTIVE INGREDIENTYCZ8EM144Q3
HYDROLYZED JOJOBA ESTERS (ACID FORM)INACTIVE INGREDIENTUDR641JW8W3
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORNINACTIVE INGREDIENT9F8ET54T053
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO3
ISODECYL NEOPENTANOATEINACTIVE INGREDIENTW60VYE24XC3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM623
LONICERA CAPRIFOLIUM FLOWERINACTIVE INGREDIENT5N1WD9784U3
LONICERA JAPONICA FLOWERINACTIVE INGREDIENT4465L2WS4Y3
MACADAMIA OILINACTIVE INGREDIENT515610SU8C3
MALIC ACID, L-INACTIVE INGREDIENTJ3TZF807X53
PHELLODENDRON AMURENSE BARKINACTIVE INGREDIENTPBG27B754G3
PHYTIC ACIDINACTIVE INGREDIENT7IGF0S7R8I3
POLYGLYCERYL-10 STEARATEINACTIVE INGREDIENT90TF85HH913
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0F3
PORPHYRA UMBILICALISINACTIVE INGREDIENT14AN0J70WO3
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UT3
RICE BRAN OILINACTIVE INGREDIENTLZO6K1506A3
SANDALWOODINACTIVE INGREDIENT3641YW25N23
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I3
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QT3
SODIUM STEAROYL LACTYLATEINACTIVE INGREDIENTIN99IT31LN3
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P83
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52960-20152960-201-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 458 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCLOTH / TOPICAL4.2 mgExact identifier — unii candidate
61 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY, METERED / NASAL1.2 mg/1mlExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / SUBCUTANEOUSNAExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SOINTMENT / TOPICAL1.2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii candidate
61 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / RECTAL904 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBARACHNOIDADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM LACTATESODIUM LACTATETU7HW0W0QTINJECTION, SOLUTION / INFILTRATION0.17 %v/vExact identifier — unii candidate
7 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLELIXIR / ORAL90 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-ARTERIAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IDISC / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / SUBLINGUALADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / OPHTHALMIC0.5 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE / ORAL1488 mgExact identifier — unii candidate
27 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IOINTMENT, AUGMENTED / TOPICAL0.11 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, CHEWABLE / ORAL11.8 mgExact identifier — unii candidate
27 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS78.36 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET / ORAL10 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS81 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EXTENDED RELEASE / ORAL312 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / ORAL11 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRATHECAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISYRUP / ORAL71 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates

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
d21fa970-c7f7-4f19-af10-15beec6582721d7f1ddb-108f-49f4-baf4-5a457ff5e08e2012-10-26WarningsExact identifier
spl id: d21fa970-c7f7-4f19-af10-15beec658272
spl set id: 1d7f1ddb-108f-49f4-baf4-5a457ff5e08e

Reported adverse events (FAERS/openFDA)#

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