PAULAS CHOICE CALM REDNESS RELIEF SPF 30 MINERAL MOISTURIZER (NORMAL TO DRY)- titanium dioxide, zinc oxide lotion

Paulas Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry) by

Drug Labeling and Warnings

Paulas Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry) by is a Otc medication manufactured, distributed, or labeled by Paula's Choice, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 3.85%

Zinc Oxide 3.12%

PURPOSE

Sunscreen

Uses

Helps prevent sunburn. Decreases the risk of skin cancer and early skin agining caused by the sun if used as directed with other sun protection measures (see Directions).

Warnings

For external use only. Do not use on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash and irritation develops and lasts. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.

Keep out of reach of children.

Keep out of eyes. Rinse with water to remove.

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

Stop use if rash and irritation develop and lasts.

Other Information

Store at 20-25°C (68-77°F). You may report serious adverse reactions to 705 5th Avenue South, Suite 200, Seattle, WA 98104.

INACTIVE INGREDIENT

Water (Aqua), C12-15 Alkyl Benzoate, Isononl Isononanoate, Prunus Armeniaca (Apricot) Kernel Oil, Glyceryl Stearate, PEG-100 Stearate, Cyclopentasiloxane, Butylene Glycol, Pentylene Glycol, Cetearyl Alcohol, Dimethicone, VP/Eicosene Copolymer, Glycine Soja (Soybean) Sterols, 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, Tibehenin, Peg-10 Phytosterol, Sorbitan Stearate, Polyhydroxystearic Acid, Alumina, Polysorbate 20, Aluminum Stearate, Xanthan Gum, Caprylyl Glycol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Chlorphenesin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAULAS CHOICE CALM REDNESS RELIEF SPF 30 MINERAL MOISTURIZER (NORMAL TO DRY) 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-913
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
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SOY STEROL (UNII: PL360EPO9J)
OAT (UNII: Z6J799EAJK)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
UBIDECARENONE (UNII: EJ27X76M46)
DIMETHICONE (UNII: 92RU3N3Y1O)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
WATER (UNII: 059QF0KO0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-913-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2016
2	NDC: 76144-913-02	15 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2016
3	NDC: 76144-913-03	2 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2016

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