NDC Code(s) : 61543-7755-6, 61543-7755-3
Packager : CCA Industries, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SOLAR SENSE CLEAR ZINC SUNSCREEN FACE and BODY SPORT BROAD SPECTRUM SPF 50 PlusOCTISALATE, OCTINOXATE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61543-7755
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
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE145 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIAZOLIDINYL UREA(UNII: H5RIZ3MPW4)
SUNFLOWER OIL(UNII: 3W1JG795YI)
NEOPENTYL GLYCOL DIHEPTANOATE(UNII: 5LKW3C543X)
OCTYLDODECANOL(UNII: 461N1O614Y)
PEG-8 DIMETHICONE(UNII: GIA7T764OD)
PEG/PPG-20/15 DIMETHICONE(UNII: 06R6X77P9C)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
CRANBERRY SEED OIL(UNII: 73KDS3BW5E)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61543-7755-61 in 1 CARTON 01/08/2013
1150 mL in 1 TUBE Type 0: Not a Combination Product
2NDC:61543-7755-390 mL in 1 TUBE Type 0: Not a Combination Product01/12/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 08/01/2013

PRINCIPAL DISPLAY PANEL

Solar Sense
Broad Spectrum
SPF 50
3 FL OZ/90ML

Solar Sense Broad Spectrum SPF 50 3 FL OZ/90ML