P.CALM WATER BARRIER SUNCREAM- ethylhexyl triazone,terephthalylidene dicamphor sulfonic acid, polysilicone-15, diethylamino hydroxybenzoyl hexyl benzoate, bis-ethylhexyloxyphenol methoxyphenyl triazine cream 
LIFE WITH CORPORATION Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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83735-001_P.CALM Water Barrier Sun Cream

ETHYLHEXYL TRIAZONE 2.7%
TEREPHTHALYLIDENE DICAMPHOR SULFONIC ACID 2.64% 
POLYSILICONE-15 1%
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 1%
BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE 0.5%

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours


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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

For external use only

Do not use on damaged or broken skin

Stop using and ask a doctor if rash occurs

When using this product, keep out of eyes. Rinse with water to remove

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

WATER, PROPANEDIOL, BUTYLOCTYL SALICYLATE, DIBUTYL ADIPATE, NIACINAMIDE, TROMETHAMINE, POLYGLYCERYL-3 DISTEARATE, OCTYLDODECANOL, CETEARYL ALCOHOL, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, CAPRYLYL METHICONE, POLYMETHYLSILSESQUIOXANE, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, METHYLPROPANEDIOL, POLY C10-30 ALKYL ACRYLATE, CARBOMER, GLYCERYL STEARATE CITRATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ADENOSINE, POLYETHER-1, SODIUM GUAIAZULENE SULFONATE, BIOSACCHARIDE GUM-1, CERAMIDE NP, ALLANTOIN, GLUTATHIONE, MADECASSOSIDE, LACTOBACILLUS FERMENT, BUTYLENE GLYCOL, ALOE FEROX LEAF EXTRACT

image description

P.CALM WATER BARRIER SUNCREAM 
ethylhexyl triazone,terephthalylidene dicamphor sulfonic acid, polysilicone-15, diethylamino hydroxybenzoyl hexyl benzoate, bis-ethylhexyloxyphenol methoxyphenyl triazine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83735-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL5 mg  in 1 mL
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4) ETHYLHEXYL TRIAZONE27 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE26.4 mg  in 1 mL
POLYSILICONE-15 (UNII: F8DRP5BB29) (POLYSILICONE-15 - UNII:F8DRP5BB29) POLYSILICONE-1510 mg  in 1 mL
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIBUTYL ADIPATE (UNII: F4K100DXP3)  
PROPANEDIOL (UNII: 5965N8W85T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
NIACINAMIDE (UNII: 25X51I8RD4)  
TROMETHAMINE (UNII: 023C2WHX2V)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
ADENOSINE (UNII: K72T3FS567)  
SODIUM GUALENATE (UNII: 19WSH095WP)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
CERAMIDE NP (UNII: 4370DF050B)  
ALLANTOIN (UNII: 344S277G0Z)  
GLUTATHIONE (UNII: GAN16C9B8O)  
MADECASSOSIDE (UNII: CQ2F5O6YIY)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALOE FEROX LEAF (UNII: 0D145J8EME)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83735-001-021 in 1 CARTON10/17/2023
1NDC:83735-001-0150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/17/2023
Labeler - LIFE WITH CORPORATION Inc. (695397552)
Registrant - LIFE WITH CORPORATION Inc. (695397552)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(83735-001)

Revised: 10/2023
Document Id: 07edd9bd-1159-44fa-e063-6394a90a2097
Set id: 2dc19f13-1dad-470e-8267-3c72267f3156
Version: 1
Effective Time: 20231017
 
LIFE WITH CORPORATION Inc.