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, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

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Paula's Choice Lipscreen SPF 50

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

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.

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

Stop use if rash occurs.

Ask a doctor if rash occurs.

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

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.

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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
YELLOW WAX (UNII: 2ZA36H0S2V)
CERESIN (UNII: Q1LS2UJO3A)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
COCOA BUTTER (UNII: 512OYT1CRR)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SHEANUT OIL (UNII: O88E196QRF)
TOCOPHEROL (UNII: R0ZB2556P8)
OLIVE OIL (UNII: 6UYK2W1W1E)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-256-01	4.15393 mL in 1 TUBE; Type 0: Not a Combination Product	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, LLC (029583981)

Revised: 1/2022

Document Id: c54e1173-70ed-02d7-e053-2a95a90a76ee

34390-5

Set id: 19b02142-0306-4faf-e054-00144ff8d46c

Version: 4

Effective Time: 20220106