7970- 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. 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

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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7970- RESIST Skin Restoring Moisturizer SPF 50

Avobenzone 3.00%
Homosalate 5.00%
Octinoxate 7.49%
Octisalate 5.00%
Oxybenzone 5.00%

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 useonly. When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask doctor if rash occur.

If swallowed, get medical help or contact 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

Protect the product in this container from excessive heat and direct sun. Store at 20-25degrees Celcius.

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	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
NIACINAMIDE (UNII: 25X51I8RD4)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
APPLE (UNII: B423VGH5S9)
ALLANTOIN (UNII: 344S277G0Z)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
SARCOSINE (UNII: Z711V88R5F)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)
MALTOOLIGOSYL GLUCOSIDE (UNII: N91S91EFOG)
DIMETHICONOL (70 CST) (UNII: MOT8IL21AR)
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ATRACTYLODES MACROCEPHALA ROOT (UNII: 08T3N29QJB)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
OAT (UNII: Z6J799EAJK)
MAHONIA AQUIFOLIUM ROOT (UNII: 746TB9VNDP)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PURSLANE (UNII: M6S840WXG5)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-797-01	60 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package	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 (029583981)

Revised: 12/2022

Document Id: f062b7c2-881f-2d45-e053-2995a90a61c7

34390-5

Set id: f062b7c2-881e-2d45-e053-2995a90a61c7

Version: 1

Effective Time: 20221221