NDC Code(s) : 75936-126-01, 75936-126-02, 75936-126-03, 75936-126-04
Packager : Taylor James LTD

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CC Cream Daily Correct Broad Spectrum SPF 40 Sunscreen Fair to Light Titanium Dioxide, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75936-126
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 DIOXIDE2 g in 100 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE20 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PROPANEDIOL(UNII: 5965N8W85T)
DIMETHICONE(UNII: 92RU3N3Y1O)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
GLYCERIN(UNII: PDC6A3C0OX)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
MICA(UNII: V8A1AW0880)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
EDETATE SODIUM(UNII: MP1J8420LU)
GLUCONOLACTONE(UNII: WQ29KQ9POT)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
SODIUM BENZOATE(UNII: OJ245FE5EU)
STANNIC OXIDE(UNII: KM7N50LOS6)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
TOCOPHEROL(UNII: R0ZB2556P8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75936-126-021 in 1 BOX 12/04/2013
1NDC:75936-126-0147 mL in 1 TUBE Type 0: Not a Combination Product
2NDC:75936-126-033 mL in 1 TUBE Type 0: Not a Combination Product12/04/2013
3NDC:75936-126-04300 mL in 1 TUBE Type 0: Not a Combination Product12/04/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 12/04/2013

PRINCIPAL DISPLAY PANEL

CC Cream Daily Correct Broad Spectrum SPF 40 Sunscreen

Fair to Light

Self-Adjusting Shade

PA+++

Supergoop!

Paraben, Fragrance, and Oxybenzone Free

1.6 fl oz/47 ml.

Primary

Primary