NDC Code(s) : 55560-0106-1
Packager : Andalou naturals

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

1000 Roses CC Color Plus Correct Sheer Tan SPF 30Zinc Oxide LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55560-0106
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
POLYGLYCERYL-3 PENTARICINOLEATE(UNII: 7Q0OK5DOT4)
MAGNESIUM SULFATE, UNSPECIFIED FORM(UNII: DE08037SAB)
GLYCERIN(UNII: PDC6A3C0OX)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
HYDROGENATED METHYL ABIETATE(UNII: A23O709X8O)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER(UNII: PN88NW0KPK)
CAPRYLHYDROXAMIC ACID(UNII: UPY805K99W)
GLYCERYL MONOCAPRYLATE(UNII: TM2TZD4G4A)
RHODODENDRON FERRUGINEUM LEAF(UNII: 30NOV1XI0P)
APPLE(UNII: B423VGH5S9)
VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATE(UNII: ZLW3M94UYA)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
JOJOBA OIL(UNII: 724GKU717M)
SUNFLOWER OIL(UNII: 3W1JG795YI)
ARONIA MELANOCARPA FRUIT JUICE(UNII: D2EVP827PJ)
LYCIUM BARBARUM FRUIT(UNII: 930626MWDL)
ACAI(UNII: 46AM2VJ0AW)
TEA LEAF(UNII: GH42T47V24)
ISOMALT(UNII: S870P55O2W)
SOYBEAN LECITHIN(UNII: 1DI56QDM62)
TOCOPHEROL(UNII: R0ZB2556P8)
GALACTOARABINAN(UNII: SL4SX1O487)
XANTHAN GUM(UNII: TTV12P4NEE)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55560-0106-11 in 1 CARTON 03/01/2014
158 mL in 1 TUBE TYPE 0: NOT A COMBINATION PRODUCT
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH DRUG M020 03/01/2014

LABELER - Andalou naturals(011472720)

Establishment
Name Address ID/FEI Business Operations
Sun Deep Inc 189788201 MANUFACTURE(55560-0106)

PRINCIPAL DISPLAY PANEL

MINERAL SUNSCREEN

ANDALOU
NATURALS

CC

1000 Roses®
COLOR + CORRECT

Sheer Tan
SPF 30
Alpine Rose Stem Cells +
Hyaluronic Acid + Vitamin E

Broad Spectrum SPF 30

FRUIT
STEM
CELL
SCIENCE®

SENSITIVE

NPN 80051191

2 fl oz / 58 mL

PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton