Paula’s Choice RESIST Skin Restoring Moisturizer SPF 50

Paulas Choice Resist Skin Restoring Moisturizer SPF 50 by

Drug Labeling and Warnings

Paulas Choice Resist Skin Restoring Moisturizer 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 RESIST SKIN RESTORING MOISTURIZER SPF 50- avobenzone, homosalate,octinoxate, octisalate, 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 RESIST Skin Restoring Moisturizer SPF 50

Avobenzone

Homosalate

Octinoxate

Octisalate

Oxybenzone

Sunscreen

Apply liberally 15 minutes befor esun exposure.

Use a water-resistant sunscreen if swimming or ssweating:- immediately after towel drying. At least every two hours.

Children under 6 months of age: Ask a doctor.

Sun Protecction Measures. Speding time in the sun increases your risk of skin cancer and early skin aging, To decreas this risk, regularly use a sunsscreen with a broad spectrum SPF 15 or higher and other sun protection measures, including: -Limit time in the sun, especially from 10AM-2PM. -Wear long-sleeve shirts, pants, hats and sunglasses.

Children under 6 months of age: Ask a doctor.

Children under 6 months of age: Ask a doctor.

For external use only. 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 swallowed, get medical help or contact a Poison Control Center right away.

Water (Aqua), Silica, Glycerin, Cetearyl Alcohol, Dimethicone, Butylene Glycol, Pentylene Glycol, Potassium Cetyl Phosphate, Cyclopentasiloxane, Pyrus Malus (Apple) Fruit Extract, VP/Eicosene Copolymer, Butyrospermum Parkii (Shea) Butter, Allantoin, Niacinamide, Tocopherol, Glycyrrhiza Glabra (Licorice) Root Extract, Aloe Barbadensis Leaf Juice, Atractylodes Macrocephala Root Powder, Avena Sativa (Oat) Kernel Extract, Coffea Arabica (Coffee) Seed Extract, Portulaca Oleracea Extract, Mahonia Aquifolium Root Extract, Diethylhexyl Syringylidenemalonate, Sarcosine, Capryloyl Glycine, Maltooligosyl Glucoside, Cetearyl Glucoside, Dimethiconol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydrogenated Starch Hydrolysate, Hexylene Glycol, 4-T-Butylcyclohexanol, Glyceryl Stearate, PEG-100 Stearate, Sodium Hydroxide, Xanthan Gum, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin.

PAULAS CHOICE RESIST SKIN RESTORING MOISTURIZER SPF 50 
avobenzone, homosalate,octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-797
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.9 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SARCOSINE (UNII: Z711V88R5F)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PORTULACA OLERACEA SEED (UNII: M08917G08Z)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
MALTOOLIGOSYL GLUCOSIDE (UNII: N91S91EFOG)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ATRACTYLODES MACROCEPHALA ROOT (UNII: 08T3N29QJB)
MAHONIA AQUIFOLIUM ROOT (UNII: 746TB9VNDP)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
GLYCERYL STEARATE/PEG-75 STEARATE (UNII: 6PSS3TQ3UY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CYCLOMETHICONE (UNII: NMQ347994Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ALLANTOIN (UNII: 344S277G0Z)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
AVENA SATIVA LEAF (UNII: 206PI19V7R)
COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
MALUS DOMESTICA FLOWER (UNII: EF626V855K)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-797-00	60 mL in 1 CARTON; Type 0: Not a Combination Product	07/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/10/2017

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

Revised: 1/2022

Document Id: d4f44083-d0bd-1ae8-e053-2995a90a502f

34390-5

Set id: d4f44083-d0bc-1ae8-e053-2995a90a502f

Version: 1

Effective Time: 20220106