M SUIT CUSHION- titanium dioxide, octinoxate, zinc oxide, octisalate liquid

M Suit Cushion by

Drug Labeling and Warnings

M Suit Cushion by is a Otc medication manufactured, distributed, or labeled by Cnt Dream. Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide, Ethylhexyl Methoxycinnamate, Zinc Oxide, Ethylhexyl Salicylate

INACTIVE INGREDIENT SECTION

Chamaecyparis Obtusa Leaf Extract,Cyclopentasiloxane,Butylene Glycol,Glycerin,
Cyclohexasiloxane,Sodium Hyaluronate,Caprylic/Capric Triglyceride,Cyclomethicone,
Trimethylsiloxysilicate,Arbutin,1,2-Hexanediol,Cetyl PEG/PPG-10/1 Dimethicone,
Iron Oxide Yellow(CI 77492),PEG-10 Dimethicone,Sodium Chloride,Sorbitan Sesquioleate,
Iron Oxide Red (CI 77491),Methicone,Triethoxycaprylylsilane,Lavandula Angustifolia
(Lavender) Extract,Rosmarinus Officinalis (Rosemary) Extract,Origanum Vulgare
Flower/Leaf/Stem Extract,Thymus Vulgaris (Thyme) Extract,Vaccinium Angustifolium
(Blueberry) Fruit Extract,Fragrance, Iron Oxide Black (CI77499),Ethylhexylglycerin,
Adenosine

OTC - ASK DOCTOR SECTION

*Stop use and ask a doctor if rash or irritation develops and lasts.

OTC - DO NOT USE SECTION

*Do not use on damaged or broken skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

*Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

WARNING SECTION

*For external use only
*Do not use on damaged or broken skin
*When using this product keep out of eyes, Rinse with water to remove.
*Stop use and ask a doctor if rash or irritation develops and lasts.
*Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

OTC - PURPOSE

Sunscreen

INDICATIONS & USAGE SECTION

Uses
*helps prevent sunburn
*if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Directions:
Apply a proper amount evenly for the last step of skin care.
For sunscreen use:
*apply liberally 15 minutes before sun exposure
*reapply at least every 2 hours
*use a water resistant sunscreen if swimming or sweating
*Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
*limit time in the sun, especially from 10a.m-2p.m
*wear long-sleeved shirts, pants, hats, and sunglasses
*children under 6 months of age: Ask a doctor

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

M Suit Cushion

SPF50+ PA+++

UV Protection

Net Wt. 21g/0.740Oz

INGREDIENTS AND APPEARANCE

M SUIT CUSHION 
titanium dioxide, octinoxate, zinc oxide, octisalate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71909-1237
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.05 g  in 21 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.273 g  in 21 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.84 g  in 21 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.47 g  in 21 g

Inactive Ingredients
Ingredient Name	Strength
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)	5.7561 g  in 21 g
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.168 g  in 21 g

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	65mm
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71909-1237-1	1 in 1 BOX	01/31/2018	12/31/2018
1	NDC: 71909-1237-0	21 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/31/2018

Labeler - Cnt Dream. Co., Ltd (694699750)

Registrant - Cnt Dream. Co., Ltd (694699750)

Establishment
Name	Address	ID/FEI	Business Operations
Cnt Dream. Co., Ltd		694699750	manufacture(71909-1237)