PAULAS CHOICE CALM REDNESS RELIEF SPF 30 MINERAL MOISTURIZER (NORMAL TO DRY)- 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.

----------

Paula's Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry)

Titanium Dioxide 3.85%

Zinc Oxide 3.12%

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.

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.

artwork

PAULAS CHOICE CALM REDNESS RELIEF SPF 30 MINERAL MOISTURIZER (NORMAL TO DRY) 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76144-913
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE38.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE31.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76144-913-0160 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2016
2NDC:76144-913-0215 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2016
3NDC:76144-913-032 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2016
Labeler - Paula's Choice, LLC. (029583981)

Revised: 1/2022
Document Id: c54ddf63-3873-1525-e053-2a95a90a9853
Set id: 19c2d14d-2d89-6f16-e054-00144ff8d46c
Version: 4
Effective Time: 20220106
 
Paula's Choice, LLC.