Paula's Choice PC4MEN Daytime Protect

Paulas Choice PC4MEN Daytime Protect by

Drug Labeling and Warnings

Paulas Choice PC4MEN Daytime Protect 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 PC4MEN DAYTIME PROTECT- avobenzone, homosalate, octocrylene, oxybenzone lotion 
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 PC4MEN Daytime Protect

Avobenzone 3.0%

Homosalate 7.0%

Octocrylene 2.0%

Oxybenzone 4.0%

Sunscreen

For external use only.

Do not use on damaged 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.

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

Directions

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every two hours if skin is exposed to sun.

Sun Protection Measures. Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly wear a broad-spectrum sunscreen rated SPF 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-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: ask a doctor

Protect this product from excessive heat and direct sun. You may report serious adverse reactions to 705 5th Avenue South, Suite 200, Seattle, WA 98104

Water, Butylene Glycol, Silica, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice Powder, Ascorbyl Palmitate, Phospholipids, Superoxide Dismutase, Adenosine, Tocopherol, Bisabolol, Boerhavia Diffusa Root Extract, Colloidal Oatmeal, Panthenol, Ginkgo Biloba Leaf Extract, Salix Alba (Willow) Bark Extract, Cetyl Dimethicone, Aluminum Starch Octenylsuccinate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Titanium Dioxide, Sorbic Acid, Sodium Hydroxide, Steareth-21, Steareth-2, Polysorbate 20, Disodium EDTA, Phenoxyethanol

PAULAS CHOICE PC4MEN DAYTIME PROTECT 
avobenzone, homosalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-873
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GINKGO (UNII: 19FUJ2C58T)
SALIX ALBA BARK (UNII: 205MXS71H7)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SORBIC ACID (UNII: X045WJ989B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)
OATMEAL (UNII: 8PI54V663Y)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-873-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	02/11/2014
2	NDC: 76144-873-03	2 mL in 1 PACKET; Type 0: Not a Combination Product	02/11/2014
3	NDC: 76144-873-02	15 mL in 1 TUBE; Type 0: Not a Combination Product	02/11/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/11/2014

Labeler - Paula's Choice, LLC. (029583981)

Revised: 12/2022

Document Id: f05cf990-80fc-b921-e053-2995a90a93dd

34390-5

Set id: 19c329c2-61d7-002f-e054-00144ff88e88

Version: 5

Effective Time: 20221221