2230-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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2230-Paula's Choice DEFENSE Essential Glow Moisturizer SPF 30

Titanium Dioxide - 5.25%
Zinc Oxide - 6.12%

Helps prevent sunburn

If used directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

For external use only

When using this product with other sun protection measures, decreases the risk of skin cancer and early sking aging caused by the sun.

Stop use and ask doctor if rash occur.

If swallowed, get medical help or contact a Poison Control Center right away.

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

Sun Protection Measures.
Spending time in the su increases your risk of skin cancer and early skin aging.
To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures, including:
-Limit timw in the sun, especially from 10am-2pm
-Wear long-sleeve shirts, pants, hats, and sunglasses

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

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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	52.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	61.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PULLULAN (UNII: 8ZQ0AYU1TT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
KIWI FRUIT (UNII: 71ES77LGJC)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
TETRAPEPTIDE-3 (UNII: 90AX5T9G36)
LEVOMENOL (UNII: 24WE03BX2T)
SOY STEROL (UNII: PL360EPO9J)
LUTEIN (UNII: X72A60C9MT)
SODIUM GLUCONATE (UNII: R6Q3791S76)
ALUMINUM OXIDE (UNII: LMI26O6933)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
XANTHAN GUM (UNII: TTV12P4NEE)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GLYCERIN (UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ARGAN OIL (UNII: 4V59G5UW9X)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
RESVERATROL (UNII: Q369O8926L)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LAURETH-7 (UNII: Z95S6G8201)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-223-00	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: 12/2022

Document Id: f0635449-f537-63ae-e053-2a95a90a0e70

34390-5

Set id: f0635449-f536-63ae-e053-2a95a90a0e70

Version: 1

Effective Time: 20221221