P.CALM WATER BARRIER SUNSCREEN SPF 50 BROAD SPECTRUM- homosalate, octisalate, octocrylene, avobenzone lotion

P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum by

Drug Labeling and Warnings

P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by LIFE WITHCORPORATION Inc., Kolmar Korea Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 2.7%

Octisalate 4.5%

Homosalate13.5%

Octocrylene 9%

PURPOSE

sunscreen

INDICATIONS & USAGE

• 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

For external use only

Do not use

• on damaged skin or broken skin

When using this product

• keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if rash occurs

• rash occurs

Keep out of reach of children

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

• 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

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

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

P.CALM Water Barrier Sunscreen

SPF 50+ Broad Spectrum

Panthenol, Hydrolyzed Sodium Hyaluronate, Centella Asiatica Extract

50 ml - 1.69 fl.oz

INGREDIENTS AND APPEARANCE

P.CALM WATER BARRIER SUNSCREEN SPF 50 BROAD SPECTRUM 
homosalate, octisalate, octocrylene, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83735-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
PANTHENOL (UNII: WV9CM0O67Z)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TROMETHAMINE (UNII: 023C2WHX2V)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SILICA (UNII: ETJ7Z6XBU4)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83735-002-02	1 in 1 BOX	02/01/2026
1	NDC: 83735-002-01	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
OTC Monograph Drug	M020	02/01/2026

Labeler - LIFE WITHCORPORATION Inc. (695397552)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd		963271745	manufacture(83735-002)