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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
CANDELILLA WAX (UNII: WL0328HX19)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
RICE BRAN OIL (UNII: LZO6K1506A)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)  
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
BARLEY (UNII: 5PWM7YLI7R)  
MACADAMIA OIL (UNII: 515610SU8C)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
SANDALWOOD (UNII: 3641YW25N2)  
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MALIC ACID, L- (UNII: J3TZF807X5)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
ALCOHOL (UNII: 3K9958V90M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DOCOSANOL (UNII: 9G1OE216XY)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
PHYTIC ACID (UNII: 7IGF0S7R8I)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52960-201-1245 g in 1 TUBE
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)

Revised: 10/2012
Document Id: d21fa970-c7f7-4f19-af10-15beec658272
Set id: 1d7f1ddb-108f-49f4-baf4-5a457ff5e08e
Version: 3
Effective Time: 20121026
 
iBlanc, Inc.