Paula's Choice SPF 50 Broad Spectrum 5% Vitamin C Sheer Moisturizer

Paulas Choice by

Drug Labeling and Warnings

Paulas Choice by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAULAS CHOICE BROAD SPECTRUM SPF 50- avobenzone, octinoxate, octisalate, octocrylene lotion 
Prime Enterprises

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Paula's Choice SPF 50 Broad Spectrum 5% Vitamin C Sheer Moisturizer

Active Ingredients

Avobenzone 2%

Octinoxate 7.5%

Octisalate 5%

Octocrylene 2%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

When using this product

keep out of eyes. Rinse with water to remove

Do not use

on damaged or broken skin

Stop use and ask a doctor if

rash occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • SHAKE WELL. Apply liberally 15 minutes before sun exposure
  • Use a water-resistant sunscreen if swimming or sweating
  • Reapply:
  • immediately after towel drying
  • at least every two hours
  • 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 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 am - 2 pm
  • wear long-sleeve shirts, pants, hats and sunglasses

Other Information

protect the product in this container from excessive heat and direct sun. Store at 20 - 25 °C (68 - 77 °F)

Inactive Ingredients

Water, Glycerin, Silica, 3-O-Ethyl Ascorbic Acid, Ascorbyl Glucoside, Dimethicone, Propanediol, Tetrahexyldecyl Ascorbate, Acetyl Zingerone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Diethylhexyl Syringylidenemalonate, Dimethicone/Vinyl Dimethicone Crosspolymer, Entada Phaseoloides Bark/Seed Extract, Porphyra Umbilicalis Extract, Hydrogenated Lecithin, Ricinus Communis (Castor) Seed Oil, Sodium Hydroxide, Tocopherol, Xanthan Gum, Ethylhexylglycerin, Laureth-4, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Titanium Dioxide, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Questions or Comments?

Call 1.800.831.4088 (U.S. and Canada) Mon-Fri 6 am - 6 pm PT | Sat-Sun 8 am - 4:30 pm PT

Principal Display Label

PAULAS CHOICE  BROAD SPECTRUM SPF 50
avobenzone, octinoxate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58443-0660
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE21 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE78.75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE52.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE21 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LAURETH-4 (UNII: 6HQ855798J)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
ACETYL ZINGERONE (UNII: V9D92S9YE5)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
ENTADA PHASEOLOIDES SEED (UNII: 4R80X8KTM7)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PROPANEDIOL (UNII: 5965N8W85T)  
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
WATER (UNII: 059QF0KO0R)  
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)  
Product Characteristics
Colorbrown (Nude/Peach) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58443-0660-215 mL in 1 TUBE; Type 0: Not a Combination Product05/17/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/2024
Labeler - Prime Enterprises (101946028)
Registrant - Prime Enterprises (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises101946028analysis(58443-0660) , label(58443-0660) , manufacture(58443-0660) , pack(58443-0660)

Revised: 6/2024
 

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