P.calm Water Barrier Sunscreen Spf 50+ Broad Spectrum

P.calm Water Barrier Sunscreen Spf 50+ Broad Spectrum
SPL v1
SPL
SPL Set ID 44ea9fb4-8e01-6969-e063-6294a90a6a94
Route
TOPICAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.7 g) Octisalate (4.5 g) Octocrylene (9 g) Homosalate (13.5 g)
Inactive Ingredients
Ethylhexylglycerin Tocopherol Centella Asiatica Panthenol 1,2-hexanediol Tromethamine Cetyl Alcohol Sodium Hyaluronate C20-22 Alcohols Polymethylsilsesquioxane (4.5 Microns) Pentylene Glycol Caprylyl Methicone Camellia Sinensis Leaf C20-22 Alkyl Phosphate Diethylhexyl 2,6-naphthalate Dipropylene Glycol Glyceryl Stearate Polyacrylate Crosspolymer-6 Ammonium Acryloyldimethyltaurate/vp Copolymer Butylene Glycol Butyloctyl Salicylate Silica Vinylpyrrolidone/eicosene Copolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-02-01
Description

Avobenzone 2.7% Octisalate 4.5% Homosalate13.5% Octocrylene 9%

Medication Information

Warnings and Precautions

For external use only

Indications and 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
Dosage and Administration
  • 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
Description

Avobenzone 2.7% Octisalate 4.5% Homosalate13.5% Octocrylene 9%

Section 42229-5
  • 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
Section 51727-6

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

Section 51945-4

P.CALM Water Barrier Sunscreen

SPF 50+ Broad Spectrum

Panthenol, Hydrolyzed Sodium Hyaluronate, Centella Asiatica Extract

50mL - 1.69 fl.ox

Section 55105-1

sunscreen

Section 55106-9

Avobenzone 2.7%

Octisalate 4.5%

Homosalate13.5%

Octocrylene 9%

Do Not Use
  • on damaged skin or broken skin
Package Label

P.CALM Water Barrier Sunscreen

SPF 50+ Broad Spectrum

Panthenol, Hydrolyzed Sodium Hyaluronate, Centella Asiatica Extract

50 ml - 1.69 fl.oz

When Using This Product
  • keep out of eyes. Rinse with water to remove
Keep Out of Reach of Children

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

Stop Use and Ask A Doctor If Rash Occurs
  • rash occurs

Structured Label Content

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)
  • 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
Warnings and Precautions (34071-1)

For external use only

Section 42229-5 (42229-5)
  • 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
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

P.CALM Water Barrier Sunscreen

SPF 50+ Broad Spectrum

Panthenol, Hydrolyzed Sodium Hyaluronate, Centella Asiatica Extract

50mL - 1.69 fl.ox

Section 55105-1 (55105-1)

sunscreen

Section 55106-9 (55106-9)

Avobenzone 2.7%

Octisalate 4.5%

Homosalate13.5%

Octocrylene 9%

Do Not Use (Do not use)
  • on damaged skin or broken skin
Package Label (PACKAGE LABEL)

P.CALM Water Barrier Sunscreen

SPF 50+ Broad Spectrum

Panthenol, Hydrolyzed Sodium Hyaluronate, Centella Asiatica Extract

50 ml - 1.69 fl.oz

When Using This Product (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 swallowed, get medical help or contact a Poison Control Center right away

Stop Use and Ask A Doctor If Rash Occurs (Stop use and ask a doctor if rash occurs)
  • rash occurs

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:28.091459 · Updated: 2026-03-14T23:12:40.778283