FDA.reportPublic FDA data

Paulas Choice Lipscreen SPF 50

Manufacturer
Paula's Choice, LLC
Effective date
2022-01-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:18:51

Label at a glance#

ProductPaulas Choice Lipscreen SPF 50
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Homosalate 5.0%, Octisalate 5.0%, Avobenzone 3.0%, Octocrylene 2.5%

INDICATIONS & USAGE SECTION

Helps prevent sunburn. Decreases the risk of skin cancer and early skin aging caused by the sun if used as directed with other sun protection measures.

WARNINGS SECTION

For external use only. do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop use if rash occurs.

OTC - ASK DOCTOR SECTION

Ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.

INACTIVE INGREDIENT SECTION

Hydrogenated Soybean Oil, Bis-Diglyceryl Poluacyladipate-2, Hydrogenated Olive Oil, Polyglyceryl-3 Diisostearate, Beeswax, Ozokerite, Hydrogenated Jojoba Oil, Polyethylene, Hydrogenated Polycyclopentadiena, Microcrystalline Wax, Theobrome Cacao (Cocoa) Seed Butter, Silica, Tocopheryl Acetate, Phytosterols, Olea Europaea (Olive) Fruite Oil, Hydrogenated Vegetable Oil, Copernicia Cerifera (Caranauba) Wax, Water (Aqua), Phenoxyethanol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ShrinkbandShrinkbandArtworkArtwork

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76144-256-012024-01-30C16284748780-19d75b9d0-2671-f424-e053-dadaa90a57cePaula's Choice Lipscreen SPF 50
76144-256-002020-01-31C16284748780-19d75b9d0-2671-f424-e053-dadaa90a57cePaula's Choice Lipscreen SPF 50

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76144-25676144-256-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
HYDROGENATED OLIVE OIL53839415GIIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
YELLOW WAX2ZA36H0S2VIACT
CERESINQ1LS2UJO3AIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
COCOA BUTTER512OYT1CRRIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SHEANUT OILO88E196QRFIACT
TOCOPHEROLR0ZB2556P8IACT
OLIVE OIL6UYK2W1W1EIACT
CARNAUBA WAXR12CBM0EIZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
c54e1173-70ed-02d7-e053-2a95a90a76ee19b02142-0306-4faf-e054-00144ff8d46c2022-01-06WarningsExact identifier
spl id: c54e1173-70ed-02d7-e053-2a95a90a76ee
spl set id: 19b02142-0306-4faf-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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