1460- Paulas Choice Skin Recovery Daily Moisturizing Lotion Broad Spectrum 30

Paulas Choice Skin Recovery Daily Moisturizing SPF 30 by

Drug Labeling and Warnings

Paulas Choice Skin Recovery Daily Moisturizing 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 SKIN RECOVERY DAILY MOISTURIZING SPF 30- titanium dioxide, 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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1460- Paulas Choice Skin Recovery Daily Moisturizing Lotion Broad Spectrum 30

Directions for use:
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

For external use only
When using this product keep out 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.

Children under 6: ASK A DOCTOR

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

Stop use and ask doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Stop use and ask doctor if rash occurs

Titanium Dioxide, 3.85%

Zinc Oxide, 3.12%

Sunscreen

Water (Aqua), C12-15 Alkyl Benzoate, Isononyl Isononanoate, Prunus Armeniaca (Apricot) Kernel Oil, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Pentylene Glycol, Cetearyl Alcohol, Dimethicone, Glycine Soja (Soybean) Sterols, VP/Eicosene Copolymer, Avena Sativa (Oat) Kernel Extract, Glycerin, Sodium Hyaluronate, Allantoin, Tocopheryl Acetate, Hydrogenated Lecithin, Tetrahexyldecyl Ascorbate, Superoxide Dismutase, Ubiquinone, Ceramide NG, Methicone, Palmitoyl Hexapeptide-12, PEG-10 Dimethicone, Cucumis Sativus (Cucumber) Fruit Extract, Caprylic/Capric Triglyceride, Tribehenin, PEG-10 Phytosterol, Sorbitan Stearate, Polyhydroxystearic Acid, Alumina, Polysorbate 20, Aluminum Stearate, Xanthan Gum, Caprylyl Glycol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Chlorphenesin.

PAULAS CHOICE SKIN RECOVERY DAILY MOISTURIZING SPF 30 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-146
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	38.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	31.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-100 STEARATE (UNII: YD01N1999R)
ALLANTOIN (UNII: 344S277G0Z)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CERAMIDE NG (UNII: C04977SRJ5)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CUCUMBER (UNII: YY7C30VXJT)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
OAT (UNII: Z6J799EAJK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)
CHLORPHENESIN (UNII: I670DAL4SZ)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
UBIDECARENONE (UNII: EJ27X76M46)
METHICONE (20 CST) (UNII: 6777U11MKT)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
SOY STEROL (UNII: PL360EPO9J)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-146-00	60 mL in 1 TUBE; Type 0: Not a Combination Product	06/27/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/27/2011

Labeler - Paula's Choice LLC (029583981)

Revised: 12/2022

Document Id: f06043c8-2474-364a-e053-2a95a90ad551

34390-5

Set id: f06043c8-2473-364a-e053-2a95a90ad551

Version: 1

Effective Time: 20221221