IM COOLING CICA SUNSTICK by Normalest Co., Ltd.

IM COOLING CICA SUNSTICK by

Drug Labeling and Warnings

IM COOLING CICA SUNSTICK by is a Otc medication manufactured, distributed, or labeled by Normalest Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IM COOLING CICA SUNSTICK- homosalate, ethylhexyl methoxycinnamate, ethylhexyl salicylate stick 
Normalest Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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IM COOLING CICA SUNSTICK 
homosalate, ethylhexyl methoxycinnamate, ethylhexyl salicylate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72284-0009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.04 g  in 16 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	1.28 g  in 16 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.672 g  in 16 g

Inactive Ingredients
Ingredient Name	Strength
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
ADENOSINE (UNII: K72T3FS567)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
TOCOPHEROL (UNII: R0ZB2556P8)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FIG (UNII: TGD87RII2U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)
BEMOTRIZINOL (UNII: PWZ1720CBH)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CERAMIDE NP (UNII: 4370DF050B)

Product Characteristics
Color		Score
Shape	ROUND	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72284-0009-1	1 in 1 BOX	10/23/2019
1		16 g in 1 CONTAINER; 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	10/23/2019	11/05/2019

Labeler - Normalest Co., Ltd. (694812877)

Registrant - Normalest Co., Ltd. (694812877)

Establishment
Name	Address	ID/FEI	Business Operations
Normalest Co., Ltd.		694812877	manufacture(72284-0009)

Revised: 11/2019

Document Id: 9697200a-98cb-4b4d-e053-2995a90a1c14

34390-5

Set id: 95946e70-58c7-1492-e053-2a95a90aaf56

Version: 2

Effective Time: 20191105

 

Normalest Co., Ltd.