NDC Code(s) : 68078-023-24, 68078-023-02
Packager : Colorescience

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

All Calm Clinical Redness Corrector SPF 50Titanium Dioxide and Zinc Oxide LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68078-023
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 Dioxide116 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION86 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
WATER(UNII: 059QF0KO0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
Niacinamide(UNII: 25X51I8RD4)
Disteardimonium Hectorite(UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Propylene Carbonate(UNII: 8D08K3S51E)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES(UNII: 0K5Y9U1P6M)
CHROMIC OXIDE(UNII: X5Z09SU859)
ALUMINUM OXIDE(UNII: LMI26O6933)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIMETHICONOL (100000 CST)(UNII: OSA9UP217S)
CYCLOMETHICONE 4(UNII: CZ227117JE)
JOJOBA OIL(UNII: 724GKU717M)
POLYHYDROXYSTEARIC ACID STEARATE(UNII: 8KQ7I65XZE)
Glyceryl Behenate/Eicosadioate(UNII: 73CJJ317SR)
LEVOMENOL(UNII: 24WE03BX2T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Phenoxyethanol(UNII: HIE492ZZ3T)
CRITHMUM MARITIMUM WHOLE(UNII: J7IHY79BKY)
Triethoxycaprylylsilane(UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
Tocopherol(UNII: R0ZB2556P8)
MAGNOLIA OFFICINALIS BARK(UNII: 5M609NV974)
Benzoic Acid(UNII: 8SKN0B0MIM)
GINGER(UNII: C5529G5JPQ)
Dehydroacetic Acid(UNII: 2KAG279R6R)
Glycolic Acid(UNII: 0WT12SX38S)
Chloroacetic Acid(UNII: 5GD84Y125G)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68078-023-241 in 1 CARTON 08/02/2017
130 mL in 1 TUBE Type 0: Not a Combination Product
2NDC:68078-023-021 mL in 1 PACKET Type 0: Not a Combination Product08/02/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 08/02/2017

LABELER - Colorescience(128731929)

PRINCIPAL DISPLAY PANEL

colorescience®

ALL CALM™

CLINICAL REDNESS
CORRECTOR

Instantly neutralizes redness
Soothes sensitive skin

50
Broad Spectrum
SPF 50 Sunscreen
PA++++

1 fl. oz. / 30 mL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton