P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum
Generic name: HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Manufacturer: LIFE WITHCORPORATION Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 44ea9fb4-8e01-6969-e063-6294a90a6a94
SPL ID: 44ea9fb4-8e02-6969-e063-6294a90a6a94
Version: 1
Effective date: 2025-12-01
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:27:58

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M020	openfda.application_number
brand name		P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum	openfda.brand_name
generic name		HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	openfda.generic_name
manufacturer name		LIFE WITHCORPORATION Inc.	openfda.manufacturer_name
ndc	package	83735-002-02	openfda.package_ndc
ndc	package	83735-002-01	openfda.package_ndc
ndc	product	83735-002	openfda.product_ndc
ndc11	package	83735000202	derived:openfda.package_ndc
ndc11	package	83735000201	derived:openfda.package_ndc
spl id		44ea9fb4-8e02-6969-e063-6294a90a6a94	id
spl set id		44ea9fb4-8e01-6969-e063-6294a90a6a94	set_id
unii		5A68WGF6WM	openfda.unii
unii		V06SV4M95S	openfda.unii
unii		G63QQF2NOX	openfda.unii
unii		4X49Y0596W	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

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

Reported adverse events (FAERS/openFDA)#

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