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

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

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:58443-0660-360 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: 5/2024
Document Id: 18aaad5b-3399-ed6c-e063-6294a90a7529
Set id: 18aaad5b-3398-ed6c-e063-6294a90a7529
Version: 1
Effective Time: 20240517
 
Prime Enterprises