NDC Code(s) : 61380-303-27
Packager : Levlad, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Natures Gate Face Broad Spectrum Sunscreen SPF 25OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61380-303
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE70 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE69 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN(UNII: 344S277G0Z)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CETYL DIMETHICONE 25(UNII: U4AS1BW4ZB)
CHAMOMILE(UNII: FGL3685T2X)
COCO-CAPRYLATE(UNII: 4828G836N6)
COCONUT OIL(UNII: Q9L0O73W7L)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CUCUMBER(UNII: YY7C30VXJT)
ECHINACEA ANGUSTIFOLIA(UNII: VB06AV5US8)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL 1-UNDECYLENATE(UNII: B68LJT9544)
MAGNESIUM ASCORBYL PHOSPHATE(UNII: 0R822556M5)
METHYL GLUCOSE SESQUISTEARATE(UNII: V1YW10H14D)
DEXPANTHENOL(UNII: 1O6C93RI7Z)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FYTIC ACID(UNII: 7IGF0S7R8I)
ALMOND(UNII: 3Z252A2K9G)
ROSA CANINA SEED(UNII: 4503R1M9UT)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
TOMATO(UNII: Z4KHF2C175)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EICOSYL POVIDONE(UNII: XQQ9MKE2BJ)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61380-303-27118 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 NOT FINAL part352 11/20/2012

PRINCIPAL DISPLAY PANEL

NATURE'S
GATE ®

FACE

Sunscreen

Broad Spectrum
SPF 25

Water Resistant
(40 minutes)

4 FL OZ / 118 mL

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label