NDC Code(s) : 55560-0103-1
Packager : Andalou naturals

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

1000 Roses Daily Shade Facial SPF 18Octisalate, Octocrylene, and Avobenzone LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55560-0103
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE50 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE50 mg in 1 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL STEARATE CITRATE(UNII: WH8T92A065)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CETYL ALCOHOL(UNII: 936JST6JCN)
STEARIC ACID(UNII: 4ELV7Z65AP)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
SUNFLOWER OIL(UNII: 3W1JG795YI)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
DIMETHICONE(UNII: 92RU3N3Y1O)
SOYBEAN LECITHIN(UNII: 1DI56QDM62)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: F68VH75CJC)
APPLE(UNII: B423VGH5S9)
XANTHAN GUM(UNII: TTV12P4NEE)
ACAI(UNII: 46AM2VJ0AW)
ARONIA MELANOCARPA FRUIT JUICE(UNII: D2EVP827PJ)
LYCIUM BARBARUM FRUIT(UNII: 930626MWDL)
TOCOPHEROL(UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
PANTHENOL(UNII: WV9CM0O67Z)
ALLANTOIN(UNII: 344S277G0Z)
MAGNESIUM ASCORBYL PHOSPHATE(UNII: 0R822556M5)
VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATE(UNII: ZLW3M94UYA)
RHODODENDRON FERRUGINEUM LEAF(UNII: 30NOV1XI0P)
ISOMALT(UNII: S870P55O2W)
ALCOHOL(UNII: 3K9958V90M)
ASPALATHUS LINEARIS LEAF(UNII: H7UGK1GJCU)
TEA LEAF(UNII: GH42T47V24)
HIBISCUS SABDARIFFA FLOWER(UNII: 45TGG6IU6M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55560-0103-11 in 1 CARTON 03/01/2014
180 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(55560-0103)

PRINCIPAL DISPLAY PANEL

SUNSCREEN

ANDALOU
NATURALS

1000 Roses®
DAILY SHADE

Facial Lotion
SPF 18

with Alpine Rose Stem Cells
& Vitamins E & C

Broad Spectrum SPF 18

FRUIT
STEM
CELL
SCIENCE®

SENSITIVE

2.7 fl oz / 80 mL

Principal Display Panel - 80 mL Tube Carton