Paula's Choice DEFENSE Essential Glow Moisturizer SPF 30

Paulas Choice DEFENSE Essential Glow Moisturizer SPF 30 by

Drug Labeling and Warnings

Paulas Choice DEFENSE Essential Glow Moisturizer 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 DEFENSE ESSENTIAL GLOW MOISTURIZER SPF 30- zinc oxide, titanium dioxide 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 DEFENSE Essential Glow Moisturizer SPF 30

Zinc Oxide - 6.125%
Titanium Dioxide - 5.25%

• Apply liberally 15 minutes before sun exposure
• Use a water-resistant sunscreen if swimming or sweating: immediatelly after towel drying; At least every two hours.
• Children under 6 months of age: Ask a doctor.

For external use only.

Stop use if rash occurs.

Ask a doctor if rash occurs.

When using this product, keep out of eyes. Rinse with water to remove.

Stop use if rash occurs

Protect the product in this container from excessive heat and direct sun. Store at 20-25C (68-77F)

Water (Aqua), C12-15 Alkyl Benzoate, Glycerin, Isononyl Isononanoate, Butylene Glycol, Cetearyl Alcohol, Potassium Cetyl Phosphate, Dimethicone, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Argania Spinosa Kernel Oil, Tetrapeptide-30, Linoleic Acid, Resveratrol, Ascorbyl Glucoside, Niacinamide, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Bisabolol, Tocopherol, Phospholipids, Lecithin, Glycine Soja (Soybean) Sterols, Xanthophylls, Pullulan, Sodium Gluconate, Xanthan Gum, Sclerotium Gum, Alumina, Caprylic/Capric Triglyceride, Citric Acid, Triethoxycaprylylsilane, C13-14 Isoparaffin, Acrylates Copolymer, Polyhydroxystearic Acid, Caprylyl Glycol, Polyacrylamide, Ceteareth-20, Aluminum Stearate, Laureth-7, Ethylhexylglycerin, Phenoxyethanol.

Sunscreen

PAULAS CHOICE DEFENSE ESSENTIAL GLOW MOISTURIZER SPF 30 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-223
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	61.25 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	52.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LEVOMENOL (UNII: 24WE03BX2T)
LUTEIN (UNII: X72A60C9MT)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
SODIUM GLUCONATE (UNII: R6Q3791S76)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SOY STEROL (UNII: PL360EPO9J)
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PULLULAN (UNII: 8ZQ0AYU1TT)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
KIWI FRUIT (UNII: 71ES77LGJC)
ARGAN OIL (UNII: 4V59G5UW9X)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
RESVERATROL (UNII: Q369O8926L)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
NIACINAMIDE (UNII: 25X51I8RD4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-223-02	15 mL in 1 TUBE; Type 0: Not a Combination Product	09/10/2018
2	NDC: 76144-223-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	09/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/10/2018

Labeler - Paula's Choice LLC (029583981)

Revised: 1/2022

Document Id: c54ddd72-5d4b-218c-e053-2995a90a7cee

34390-5

Set id: 7432df12-382a-7db6-e053-2991aa0a810a

Version: 4

Effective Time: 20220106