FDA.reportPublic FDA data

P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum

Manufacturer
LIFE WITHCORPORATION Inc. | Kolmar Korea Co., Ltd
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:35:47

Label at a glance#

ProductP.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7%

Octisalate 4.5%

Homosalate13.5%

Octocrylene 9%

OTC - PURPOSE SECTION

sunscreen

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged skin or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if rash occurs

OTC - STOP USE SECTION

  • rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure

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 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses

  • children under 6 months of age: Ask a doctor
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating

SPL UNCLASSIFIED SECTION

  • protect the product from excessive heat and direct sun
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun

INACTIVE INGREDIENT SECTION

Water, Butyloctyl Salicylate, Diethylhexyl 2,6-Naphthalate, Dipropylene Glycol, Panthenol, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Caprylyl Methicone, Silica, Pentylene Glycol, Cetyl Alcohol, Glyceryl Stearate, Polymethylsilsesquioxane, VP/Eicosene Copolymer,Tromethamine, Polyacrylate Crosspolymer-6, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ethylhexylglycerin, Hydrolyzed Sodium Hyaluronate, Tocopherol, Butylene Glycol, Centella Asiatica Extract, Camellia Sinensis Leaf Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P.CALM Water Barrier Sunscreen

SPF 50+ Broad Spectrum

Panthenol, Hydrolyzed Sodium Hyaluronate, Centella Asiatica Extract

50mL - 1.69 fl.ox

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P.CALM Water Barrier Sunscreen

SPF 50+ Broad Spectrum

Panthenol, Hydrolyzed Sodium Hyaluronate, Centella Asiatica Extract

50 ml - 1.69 fl.oz

BoxBox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83735-002-01P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum50 mL in 1 TUBELOTION501
83735-002-02P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum1 in 1 BOXLOTION11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83735-00283735-002-01, 83735-002-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
CENTELLA ASIATICA7M867G6T1UIACT
PANTHENOLWV9CM0O67ZIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
AVOBENZONEG63QQF2NOXACTIB
TROMETHAMINE023C2WHX2VIACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM HYALURONATEYSE9PPT4THIACT
C20-22 ALCOHOLSO4M0347C6AIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
PENTYLENE GLYCOL50C1307PZGIACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
C20-22 ALKYL PHOSPHATEL4VKP0Y7RPIACT
HOMOSALATEV06SV4M95SACTIB
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
DIPROPYLENE GLYCOLE107L85C40IACT
GLYCERYL STEARATE230OU9XXE4IACT
POLYACRYLATE CROSSPOLYMER-6Q7UI015FF9IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SILICAETJ7Z6XBU4IACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
P.CALM Water Barrier Sunscreen SPF 50 Broad SpectrumHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONELIFE WITHCORPORATION Inc.44ea9fb4-8e01-6969-e063-6294a90a6a942025-12-01WarningsExact identifier
ndc (package): 83735-002-02
ndc (package): 83735-002-01
ndc (product): 83735-002
ndc11 (package): 83735000202
ndc11 (package): 83735000201
spl id: 44ea9fb4-8e02-6969-e063-6294a90a6a94
spl set id: 44ea9fb4-8e01-6969-e063-6294a90a6a94

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.