NDC Code(s) : 42421-576-17
Packager : Emilia Personal Care Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Safe Harbor Natural Suncare TITANIUM DIOXIDE, ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42421-576
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE9.4 g in 124 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE4.96 g in 124 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SESAME OIL(UNII: QX10HYY4QV)
SUNFLOWER OIL(UNII: 3W1JG795YI)
GLYCERIN(UNII: PDC6A3C0OX)
COCO GLUCOSIDE(UNII: ICS790225B)
COCONUT ALCOHOL(UNII: 13F4MW8Y9K)
CASTOR OIL(UNII: D5340Y2I9G)
JOJOBA OIL(UNII: 724GKU717M)
SHEA BUTTER(UNII: K49155WL9Y)
microcrystalline cellulose(UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
arachidyl alcohol(UNII: 1QR1QRA9BU)
DOCOSANOL(UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE(UNII: 6JVW35JOOJ)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
XANTHAN GUM(UNII: TTV12P4NEE)
PEG-40 STEARATE(UNII: ECU18C66Q7)
TRIMETHOXYCAPRYLYLSILANE(UNII: FZ07E4LW2M)
ALLANTOIN(UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PANTHENOL(UNII: WV9CM0O67Z)
LEVOMENOL(UNII: 24WE03BX2T)
HIPPOPHAE RHAMNOIDES FRUIT OIL(UNII: TA4JCF9S1J)
ECHINACEA PURPUREA ROOT(UNII: OS64WTR4KU)
OAT BRAN(UNII: KQX236OK4U)
CHAMOMILE(UNII: FGL3685T2X)
TILIA X EUROPAEA FLOWER(UNII: NHV2K1OUDH)
MELISSA OFFICINALIS LEAF(UNII: 50D2ZE9219)
ASPALATHUS LINEARIS LEAF(UNII: H7UGK1GJCU)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42421-576-17124 g in 1 TUBE Type 0: Not a Combination Product30/12/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/30/2016

PRINCIPAL DISPLAY PANEL

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