IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30- zinc oxide lotion

iBlanc Restora-Bright Elite Natural Sun Defense by

Drug Labeling and Warnings

iBlanc Restora-Bright Elite Natural Sun Defense by is a Otc medication manufactured, distributed, or labeled by iBlanc, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

13.5% ZINC OXIDE

PURPOSE

HELPS PREVENT SUNBURN

INDICATIONS & USAGE

WARNINGS AND PRECAUTIONS

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

STOP USE

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

QUESTIONS

QUESTIONS OR COMMENTS

CALL TOLL FREE 855-2-IBLANC

INGREDIENTS AND APPEARANCE

IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE  SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52960-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52960-201-12	45 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/23/2012

Labeler - iBlanc, Inc. (078510606)

Registrant - iBlanc, Inc. (078510606)