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

P.CALM Water Barrier Suncream by

Drug Labeling and Warnings

P.CALM Water Barrier Suncream by is a Otc medication manufactured, distributed, or labeled by LIFE WITH CORPORATION Inc., Kolmar Korea Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

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

WARNINGS

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

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83735-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH)	BEMOTRIZINOL	5 mg  in 1 mL
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4)	ETHYLHEXYL TRIAZONE	27 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439)	ECAMSULE	26.4 mg  in 1 mL
POLYSILICONE-15 (UNII: F8DRP5BB29) (POLYSILICONE-15 - UNII:F8DRP5BB29)	POLYSILICONE-15	10 mg  in 1 mL
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20)	DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83735-001-02	1 in 1 CARTON	10/17/2023
1	NDC: 83735-001-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/17/2023

Labeler - LIFE WITH CORPORATION Inc. (695397552)

Registrant - LIFE WITH CORPORATION Inc. (695397552)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd		963271745	manufacture(83735-001)