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Sunburn Soothing

Dosage form: cream
Ingredients: GLYCERIN 60mg in 1mL, DIMETHICONE 5mg in 1mL
Labeler: Supadelixir Co Ltd
NDC Code: 71200-805

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.

Sunburn Soothing

Drug Facts

Active Ingredients

Glycerin 6%, Dimethicone 0.5%

Purpose

Skin protectant

USE

Soothe and protect sunburn and sun damaged skins

Warnings

For external use only

When using this product ● do not use on damaged or broken skin

● keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if rash occurs

Keep out of reach of children if product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

● Apply sunburn or sun damaged skin after cleansing Sunscreen and toning

● Smooth evenly over face & throat

● Reapply at least every 2 hours

● Children under 6 months of age: Ask a doctor

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Squalane, Butylene Glycol, Hydrogenated Polydecene, Macadamia Ternifolia Seed Oil, 1,2- Hexanediol, Cetearyl Alcohol, Glyceryl Stearate SE, C14-22 Alcohols, Aloe Barbadensis Leaf Extract, Portulaca Oleracea Extract, Jojoba Esters, Persea Gratissima (Avocado) Oil, C12-20 Alkyl Glucoside, Cetearyl Olivate, Behenyl Alcohol, Stearic Acid, Tromethamine, Sorbitan Olivate, Hydrogenated Lecithin, Carbomer, Xanthan Gum, Cholesterol, Tocopheryl Acetate, Ceramide NP, Phytosphingosine, Palmitoyl sh-Tripeptide-4 Amide  

Distributed by                                                       

SupadElixir Co., Ltd.

# 410, Building 1, School of Medicine,

1 Kangwondaehak-gil, Chuncheon-si,

Gangwon-do, Korea

www.SE-Tripeptide.com

MADE IN KOREA

After sunburn

Advanced Anti-photoaging Cream

for sun-damaged face & body skin

Packaging

SUNBURN SOOTHING 
glycerin, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71200-805
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN60 mg  in 1 mL
DIMETHICONE (DIMETHICONE) DIMETHICONE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
MEDIUM-CHAIN TRIGLYCERIDES 
SQUALANE 
BUTYLENE GLYCOL 
HYDROGENATED POLYDECENE (550 MW) 
MACADAMIA OIL 
1,2-HEXANEDIOL 
CETOSTEARYL ALCOHOL 
GLYCERYL STEARATE SE 
C14-22 ALCOHOLS 
ALOE VERA LEAF 
PURSLANE 
JOJOBA OIL, RANDOMIZED 
AVOCADO OIL 
C12-20 ALKYL GLUCOSIDE 
CETEARYL OLIVATE 
DOCOSANOL 
STEARIC ACID 
TROMETHAMINE 
SORBITAN OLIVATE 
HYDROGENATED SOYBEAN LECITHIN 
CARBOXYPOLYMETHYLENE 
XANTHAN GUM 
CHOLESTEROL 
.ALPHA.-TOCOPHEROL ACETATE 
CERAMIDE NP 
PHYTOSPHINGOSINE 
PALMITOYL SH-TRIPEPTIDE-4 AMIDE 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:71200-805-10100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/02/2017
Labeler - Supadelixir Co Ltd (688481952)
Establishment
NameAddressID/FEIOperations
Supadelixir Co Ltd688481952manufacture(71200-805)

 
Supadelixir Co Ltd

Medically reviewed on Feb 1, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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