Label: P.CALM WATER BARRIER SUNCREAM- ethylhexyl triazone,terephthalylidene dicamphor sulfonic acid, polysilicone-15, diethylamino hydroxybenzoyl hexyl benzoate, bis-ethylhexyloxyphenol methoxyphenyl triazine cream
- NDC Code(s): 83735-001-01, 83735-001-02
- Packager: LIFE WITH CORPORATION Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated October 17, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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 sunglassesAsk a doctor to use for children under 6 months
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
P.CALM WATER BARRIER SUNCREAM
ethylhexyl triazone,terephthalylidene dicamphor sulfonic acid, polysilicone-15, diethylamino hydroxybenzoyl hexyl benzoate, bis-ethylhexyloxyphenol methoxyphenyl triazine creamProduct 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. 689512611 manufacture(83735-001)
