OTC Medication Information: M Suit Cushion

M SUIT CUSHION- zinc oxide, titanium dioxide, octinoxate and octisalate liquid
Cnt Dream. 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.

OTC — ACTIVE INGREDIENT SECTION

OTC -- ACTIVE INGREDIENT SECTION
(click image for full-size original)

Titanium Dioxide, Ethylhexyl Methoxycinnamate, Zinc Oxide, Ethylhexyl Salicylate

INACTIVE INGREDIENT SECTION

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

OTC -- ASK DOCTOR SECTION

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

OTC — DO NOT USE SECTION

OTC -- DO NOT USE SECTION

*Do not use on damaged or broken skin

OTC — KEEP OUT OF REACH OF CHILDREN SECTION

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

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

OTC -- PURPOSE

Sunscreen

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

M Suit Cushion

SPF50+ PA+++

UV Protection

Net Wt. 21g/0.740Oz

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.84 g in 21 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.47 g in 21 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 1.05 g in 21 g
OCTISALATE (OCTISALATE) OCTISALATE 0.273 g in 21 g
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 0.168 g in 21 g
CHAMAECYPARIS OBTUSA LEAF 5.7561 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 Multilevel Packaging
1 NDC:71909-1237-1 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC (71909-1237-0)
1 NDC:71909-1237-0 21 g in 1 BOTTLE, PLASTIC This package is contained within the BOX (71909-1237-1)
Image of Product
(click image for full-size original)
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 Operations
Cnt Dream. Co., Ltd 694699750 manufacture (71909-1237)

Revised: 10/2020 Cnt Dream. Co., Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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