NDC Code(s) : 10967-651-51, 10967-651-24
Packager : Revlon Consumer Products Corp

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

American Crew All In One Face Balm Broad Spectrum SPF 15Octisalate,Homosalate,Avobenzone,Octocrylene LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-651
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 mg in 1 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE5 mg in 1 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE2 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
SQUALANE(UNII: GW89575KF9)
GLYCERIN(UNII: PDC6A3C0OX)
DIMETHICONE(UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
BEHENTRIMONIUM CHLORIDE(UNII: X7GNG3S47T)
POLYQUATERNIUM-37 (10000 MPA.S)(UNII: 41QWS48DFN)
.ALPHA.-BISABOLOL, (+/-)-(UNII: 36HQN158VC)
DEXPANTHENOL(UNII: 1O6C93RI7Z)
4-HYDROXY ACETOPHENONE(UNII: G1L3HT4CMH)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
ALLANTOIN(UNII: 344S277G0Z)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
FARNESOL(UNII: EB41QIU6JL)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SACCHARIDE ISOMERATE(UNII: W8K377W98I)
HYDROXYCITRONELLAL(UNII: 8SQ0VA4YUR)
BENZYL SALICYLATE(UNII: WAO5MNK9TU)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
EUGENOL(UNII: 3T8H1794QW)
GERANIOL(UNII: L837108USY)
BENZYL BENZOATE(UNII: N863NB338G)
CITRAL(UNII: T7EU0O9VPP)
CINNAMYL ALCOHOL(UNII: SS8YOP444F)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10967-651-51170 mL in 1 PACKAGE Type 0: Not a Combination Product04/01/2017
2NDC:10967-651-2450 mL in 1 PACKAGE Type 0: Not a Combination Product04/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 04/01/2017

LABELER - Revlon Consumer Products Corp(788820165)

Establishment
Name Address ID/FEI Business Operations
REVLON, INC. 809725570 manufacture(10967-651)

PRINCIPAL DISPLAY PANEL

American Crew All in One Face Balm

Broad Spectrum SPF 15

170mL

170ML

PRINCIPAL DISPLAY PANEL

American Crew All in One Face Balm

Broad Spectrum SPF 15

50mL

50mL