NDC Code(s) : 68327-071-01, 68327-071-02
Packager : Cover FX Skin Care Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cover FX Clear Cover Invisible Sunscreen Broad Spectrum SPF 30Sunscreen GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68327-071
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE10 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 g in 100 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2.6 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ISODODECANE(UNII: A8289P68Y2)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER(UNII: O4I3UFO6ZF)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SQUALANE(UNII: GW89575KF9)
DIMETHYL ISOSORBIDE(UNII: SA6A6V432S)
SESAME SEED(UNII: 7Y1255HVXR)
TOMATO(UNII: Z4KHF2C175)
TOCOPHEROL(UNII: R0ZB2556P8)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68327-071-011 in 1 CARTON 27/05/2016
130 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product
2NDC:68327-071-021 in 1 CARTON 27/05/2016
23 mL in 1 BOTTLE, PUMP 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 05/27/2016

PRINCIPAL DISPLAY PANEL

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