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

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

Drug Labeling and Warnings

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

Drug Details [pdf]

PAULAS CHOICE CALM REDNESS RELIEF SPF 30 MINERAL (NORMAL TO OILY)- zinc oxide, titanium dioxide 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.

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

Zinc Oxide 6.0%

Titanium Dioxide 2.32%

Sunscreen

Uses

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

Directions

Apply liberally 15 minutes before sun exposure. Reapply as needed or after towl drying, swimming or perspiring. 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 of 25 or greater and other sun protection measures including: -limit time in the sun, espcially from 10a.m.-2p.m. -wear lnog-sleeve shirt, pants, sunglasses and a hat.

For external use only.

Do not use on damaged or broken skin.

When usnig 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

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), Ethylhexyl Palmitate, Cyclomethicone, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, C12-15 Alkyl Benzoate, Polysorbate 80, Caprylyl Methicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Cetyl Alcohol, Propylene Glycol, Polyglyceryl-6 Isostearate, Allantoin, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Alumina, Aloe Barbadensis (Aloe) Leaf Juice, Glycerin, Panthenol, Algae Extract, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Polyhydroxystearic Acid, Triethoxysilylethyl Poldimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Butylene Glycol, Diethylhexyl Carbonate, Triethoxycaprylylsilane, Disodium EDTA, Phenoxyethanol, Chlorphenesin.

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-917
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
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CYCLOMETHICONE (UNII: NMQ347994Z)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-100 STEARATE (UNII: YD01N1999R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ISOHEXADECANE (UNII: 918X1OUF1E)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALLANTOIN (UNII: 344S277G0Z)
CHAMOMILE (UNII: FGL3685T2X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
LAMINARIA HYPERBOREA (UNII: NXA595GQ1K)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-917-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	01/30/2016
2	NDC: 76144-917-02	15 mL in 1 TUBE; Type 0: Not a Combination Product	01/30/2016
3	NDC: 76144-917-03	2 mL in 1 PACKET; Type 0: Not a Combination Product	01/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/30/2016

Labeler - Paula's Choice, LLC (029583981)

Revised: 1/2022

Document Id: c54df529-c326-dacd-e053-2995a90a60e9

34390-5

Set id: 1e15b225-d8b1-1702-e054-00144ff8d46c

Version: 4

Effective Time: 20220106