IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 - zinc oxide lotion 
iBlanc, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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13.5% ZINC OXIDE

HELPS PREVENT SUNBURN

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

KEEP OUT OF REACH OF CHILDREN.

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

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.

Advanced Sun Defense SPF30 ART 2012-08-01_LBL

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IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE  SPF 30
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52960-201
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE13.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES 
CANDELILLA WAX 
HYDROLYZED JOJOBA ESTERS (ACID FORM) 
RICE BRAN OIL 
GLYCERIN 
ISODECYL NEOPENTANOATE 
ETHYL MACADAMIATE 
ALEURITES MOLUCCANA SEED 
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN 
GLYCERYL MONOSTEARATE 
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 
ERGOTHIONEINE 
BARLEY 
MACADAMIA OIL 
PORPHYRA UMBILICALIS 
SANDALWOOD 
PHELLODENDRON AMURENSE BARK 
GLYCERYL ISOSTEARATE 
SODIUM STEAROYL LACTYLATE 
POLYGLYCERYL-10 STEARATE 
POLYHYDROXYSTEARIC ACID (2300 MW) 
TOCOPHEROL 
.ALPHA.-TOCOPHEROL ACETATE, D- 
LECITHIN, SOYBEAN 
MALIC ACID, L- 
LONICERA CAPRIFOLIUM FLOWER 
LONICERA JAPONICA FLOWER 
POTASSIUM CETYL PHOSPHATE 
HYDROGENATED PALM GLYCERIDES 
ALCOHOL 
CETOSTEARYL ALCOHOL 
DOCOSANOL 
HYPROMELLOSES 
SODIUM LACTATE 
PHYTIC ACID 
ANHYDROUS CITRIC ACID 
SODIUM HYDROXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:52960-201-1245 g in 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/23/2012

Labeler - iBlanc, Inc. (078510606)
Registrant - iBlanc, Inc. (078510606)
Establishment
NameAddressID/FEIOperations
CoValence Inc070653204manufacture

Revised: 09/2012 iBlanc, Inc.