Paula's Choice Resist Super-Light Daily Wrinkle Defense SPF 30

Paulas Choice Resist Super-Light Daily Wrinkle Defense SPF 30 by

Drug Labeling and Warnings

Paulas Choice Resist Super-Light Daily Wrinkle Defense SPF 30 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 RESIST SUPER-LIGHT DAILY WRINKLE DEFENSE SPF 30- zinc oxide 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 Resist Super-Light Daily Wrinkle Defense SPF 30

Active Ingredients

Zinc Oxide 13%

Sunscreen

Warnings

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 immediately.

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 increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum 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, Cyclopentasiloxane, PEG/PPG-18/18 Dimethicone, Dimethicone Crosspolymer, PEG-12 Dimethicone, Resveratrol, Quercetin, Epigallocatechin Gallate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Adenosine, Lauroyl Lysine, Bisabolol, Trihydroxystearin, Salix Alba (Willow) Bark Extract, Haematococcus Pluvialis Extract, Hydrolyzed Corn Starch, Polysorbate 80, Hydrolyzed Silica, Triethoxycaprylylsilane, C12-15 Alkyl Benzoate, Isopropyl Titanium Triisostearate, Caprylyl Glycol, Hexylene Glycol, Sodium Chloride, Ethylhexylglycerin, Phenoxyethanol, Iron Oxide.

PAULAS CHOICE RESIST SUPER-LIGHT DAILY WRINKLE DEFENSE SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-776
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	130 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
QUERCETIN (UNII: 9IKM0I5T1E)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAUROYL LYSINE (UNII: 113171Q70B)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
SALIX ALBA BARK (UNII: 205MXS71H7)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STARCH, CORN (UNII: O8232NY3SJ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
RESVERATROL (UNII: Q369O8926L)
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-776-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	05/22/2013
2	NDC: 76144-776-03	2 mL in 1 PACKET; Type 0: Not a Combination Product	01/21/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/22/2013

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

Revised: 1/2022

Document Id: c54e1ebf-6276-d294-e053-2995a90a96cb

34390-5

Set id: 19bd03fa-ea0e-1307-e054-00144ff88e88

Version: 5

Effective Time: 20220106