Calypso Magic Concealer Salmon Beige

Calypso Magic Concealer Salmon Beige by

Drug Labeling and Warnings

Calypso Magic Concealer Salmon Beige by is a Otc medication manufactured, distributed, or labeled by Aquacube Inc., Caring Japan Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CALYPSO MAGIC CONCEALER SALMON BEIGE- titanium dioxide lotion 
Aquacube Inc.

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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Calypso Magic Concealer Salmon Beige

Active Ingredients

Titanium Dioxide 15.5%

Purpose

Sunscreen

Warnings

Warnings When using this product

• keep out of the eye area
• rinse with water to remove
• stop use and ask a doctor if rash or irritation develops
• for external use onlyl
• keep out of reach of children

Directions

• Apply liberally before sun exposure and as needed
• children under 6 months of age: ask a doctor

Inactive Ingredients

Inactive Ingredients:

water, cyclopentasiloxane, butylene glycol, triethylhexanoin, polymethylsilsesquioxane, dimethicone, cetyl PEG/PPG-10/1 dimethicone, sorbitol, PEG-10 dimethicone, sodium hyaluronate, royal jelly extract, aloe barbadensis leaf extract, hydroxypropyltrimonium hyaluronate, soluble collagen crosspolymer, hydrolyzed hyaluronic acid, hydrolyzed collagen, soluble collagen, dipotassium glycyrrhizate, trimethylsiloxysilicate, Limnanthes alba (meadowfoam) seed oil, squalene, polyglyceryl-2 diisostearate, magnesium sulfate, triethosycaprylylsilane, hydrogen dimethicone, methicone, alumina, calcium sodium borosilicate, nylon-12, silver oxide, disteardimonium hectorite, polysorbate 80, glycerin, sodium citrate, tocopherol, disodium EDTA, phenoxyethanol, aluminum hydroxide, synthetic fluorphlogopite, iron oxides, barium sulfate, talc

CALYPSO MAGIC CONCEALER SALMON BEIGE 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79623-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	930 mg  in 6 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79623-002-01	6 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/14/2020	01/29/2021

Labeler - Aquacube Inc. (692311844)

Establishment
Name	Address	ID/FEI	Business Operations
Caring Japan Inc.		702171786	manufacture(79623-002)

Revised: 6/2021

Document Id: c5762043-7ef1-c96e-e053-2a95a90a216a

34390-5

Set id: aa6d83fc-c73e-b903-e053-2a95a90a9e94

Version: 2

Effective Time: 20210623