NDC | 71909-1237-0, 71909-1237-1 |
Set ID | 5fcb023f-e11a-7483-e053-2991aa0a4745 |
Category | HUMAN OTC DRUG LABEL |
Packager | Cnt Dream. Co., Ltd |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- OTC - ACTIVE INGREDIENT SECTION
- INACTIVE INGREDIENT SECTION
Chamaecyparis Obtusa Leaf Extract,Cyclopentasiloxane,Butylene Glycol,Glycerin,
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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 - DO NOT USE 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
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*For external use only
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*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
- 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 sunDirections:
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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
- INGREDIENTS AND APPEARANCE
M SUIT CUSHION
titanium dioxide, octinoxate, zinc oxide, octisalate liquidProduct 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 12/31/2019 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)