Label: PAULAS CHOICE CALM REDNESS RELIEF SPF 30 MINERAL MOISTURIZER (NORMAL TO DRY)- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 76144-913-01, 76144-913-02, 76144-913-03 - Packager: Paula's Choice, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 6, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
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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.
- Other Information
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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
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INGREDIENTS AND APPEARANCE
PAULAS CHOICE CALM REDNESS RELIEF SPF 30 MINERAL MOISTURIZER (NORMAL TO DRY)
titanium dioxide, zinc oxide lotionProduct 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)
