9130,9132,9137,9139-Paula's Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry)

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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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9130,9132,9137,9139-Paula's Choice Calm Redness Relief SPF 30 Mineral Moisturizer (Normal to Dry)

Titanium Dioxide, 3.85%
Zinc Oxide, 3.12%

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.

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.

Helps prevent sunburn
lf used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Instructions 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

Sun Protection Measures.
Spending time in the su increases your risk of skin cancer and early skin aging.
To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures, including:
-Limit timw in the sun, especially from 10am-2pm
-Wear long-sleeve shirts, pants, hats, and sunglasses

Protect the product in this container from excessive heat and direct sun. Store at 20-25 degrees Celcius.

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.

9130 Label

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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE31.2 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE38.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
WATER (UNII: 059QF0KO0R)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
PEG-100 STEARATE (UNII: YD01N1999R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
UBIDECARENONE (UNII: EJ27X76M46)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SOY STEROL (UNII: PL360EPO9J)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
CUCUMBER (UNII: YY7C30VXJT)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)  
CERAMIDE NG (UNII: C04977SRJ5)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OAT (UNII: Z6J799EAJK)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76144-913-0060 mL in 1 TUBE; 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 (029583981)
Registrant - Paula's Choice (029583981)

Revised: 12/2022
 

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