2560 Paula's Choice Lipscreen SPF 50

Paulas Choice Lipscreen SPF 50 by

Drug Labeling and Warnings

Paulas Choice Lipscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Paula's Choice. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAULAS CHOICE LIPSCREEN SPF 50- homosalate, octisalate, avobenzone, octocrylene lipstick 
Paula's Choice

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

2560 Paula's Choice Lipscreen SPF 50

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

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.

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

Stop use and ask doctor if rash occurs.

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.

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

PAULAS CHOICE LIPSCREEN SPF 50 
homosalate, octisalate, avobenzone, octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-256
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	25 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SHEA BUTTER (UNII: K49155WL9Y)
CARNAUBA WAX (UNII: R12CBM0EIZ)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
YELLOW WAX (UNII: 2ZA36H0S2V)
HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OLIVE OIL (UNII: 6UYK2W1W1E)
TOCOPHEROL (UNII: R0ZB2556P8)
CORN OIL (UNII: 8470G57WFM)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
CERESIN (UNII: Q1LS2UJO3A)
COCOA BUTTER (UNII: 512OYT1CRR)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-256-00	4.15393 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package	10/03/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/03/2014

Labeler - Paula's Choice (029583981)

Registrant - Paula's Choice (029583981)

Revised: 12/2022

Document Id: f08aafdd-19dd-c646-e053-2a95a90af0fc

34390-5

Set id: f08aafdd-19dc-c646-e053-2a95a90af0fc

Version: 1

Effective Time: 20221223