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

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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Sunscreen

INSTRUCTIONS FOR USE

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every two hours if skin is exposed to sun. Children under 6 months of age: ask a doctor.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 25 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m.-2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses.

WARNINGS

For external use only.

ASK DOCTOR

Children under 6 months of age: ask a doctor

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

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

STOP USE

Stop use and ask a doctor if rash and irritation develops and lasts.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun. You may report serious adverse reactions to 705 5th Avenue S, Suite 200, Seattle WA 98104

INACTIVE INGREDIENT

Water, C12-15 Alkyl Benzoate, Isononyl Isononanoate, Prunus Armeniaca (Apricot) Kernel Oil, Cylcopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Pentylene Glycol, Cetearyl Alcohol, Dimethicone, Glycine Soja (Soybean) Sterols, VP/Eicosene Copolymer, Superoxide Dismutase, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Ubiquinone, Ceramide 2, Sodium Hyaluronate, Allantoin, Avena Sativa (Oat) Kernel Extract, PEG-10 Dimethicone, Palmitoyl Oligopeptide, Tribehenin, Hydrogenated Lecithin, Polysorbate 20, Glycerin,PEG-10 Rapeseed Sterol, Caprylic/Capric Triglyceride, Methicone, Cucumis Sativus (Cucumber) Fruit Extract, Alumina, Aluminum Stearate, Polyhydroxystearic Acid, Xanthan Gum, Sorbitan Stearate, Caprylyl Glycol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Chlorphenesin.

ACTIVE INGREDIENT

Titanium Dioxide 3.85%

Zinc Oxide 3.12%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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
OAT (UNII: Z6J799EAJK)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
UBIDECARENONE (UNII: EJ27X76M46)
CERAMIDE 2 (UNII: C04977SRJ5)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHICONE (20 CST) (UNII: 6777U11MKT)
PEG-100 STEARATE (UNII: YD01N1999R)
SOY STEROL (UNII: PL360EPO9J)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CUCUMBER (UNII: YY7C30VXJT)
ALUMINUM OXIDE (UNII: LMI26O6933)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-146-01	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 (029583981)