FDA.reportPublic FDA data

Paulas Choice Lipscreen SPF 50

Manufacturer
Paula's Choice
Effective date
2022-12-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:42:29

Label at a glance#

ProductPaulas Choice Lipscreen SPF 50
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

WARNINGS AND PRECAUTIONS SECTION

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

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs.

INACTIVE INGREDIENT SECTION

Hydrogenated Soybean Oil, Bis-Diglyceryl Polyacyladipate-2, Hydrogenated Olive Oil, Polyglyceryl-3 Diisostearate, Beeswax, Ozokerite, Hydrogenated Jojoba Oil, Polyethylene, Hydrogenated Polycyclopentadiene, Microcrystalline Wax, Theobroma Cacao (Cocoa) Seed Butter, Silica, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Olea Europaea (Olive) Fruit Oil, Phytosterols, Tocopherol, Hydrogenated Vegetable Oil, Copernicia Cerifera (Carnauba) Wax, Water (Aqua), Phenoxyethanol.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

IF product is swallowed, get medical help or contact a Poisn Control Center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2560 Label2560 Label

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76144-25676144-256-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
HYDROGENATED SOYBEAN OILA2M91M918CIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SHEA BUTTERK49155WL9YIACT
CARNAUBA WAXR12CBM0EIZIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
YELLOW WAX2ZA36H0S2VIACT
HYDROGENATED JOJOBA OIL7F674YQ5SOIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
OLIVE OIL6UYK2W1W1EIACT
TOCOPHEROLR0ZB2556P8IACT
CORN OIL8470G57WFMIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
HYDROGENATED OLIVE OIL53839415GIIACT
CERESINQ1LS2UJO3AIACT
COCOA BUTTER512OYT1CRRIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
f08aafdd-19dd-c646-e053-2a95a90af0fcf08aafdd-19dc-c646-e053-2a95a90af0fc2022-12-23WarningsExact identifier
spl id: f08aafdd-19dd-c646-e053-2a95a90af0fc
spl set id: f08aafdd-19dc-c646-e053-2a95a90af0fc

Reported adverse events (FAERS/openFDA)#

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