THE GOOD STUFF AFTERSHAVE SPF 15- avobenzone, octocrylene, and octisalate cream 
Prime Enterprises Inc.

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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The Good Stuff After Shave SPF 15

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 1.85%

Purpose

Sunscreen

Uses

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 occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Water, Glycerin, C12-15 Alkyl Lactate, Dimethicone, Disodium Lauriminodipropionate Tocopheryl Phosphates, Diisopropyl Adipate, Steareth-2, Aluminum Starch Octenylsuccinate, Octyldodecyl Stearate, Steareth-21, Fragrance, Acrylamide/Sodium Acrylate Copolymer, Mineral Oil, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Trideceth-6, Disodium EDTA, Methylisothiazolinone

Other Information

Questions or comments?

The Good Stuff After Shave SPF15

Principal Display Panel

THE GOOD STUFF  AFTERSHAVE SPF 15
avobenzone, octocrylene, and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0198
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE18.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
OCTYLDODECYL STEARATE (UNII: K6F16QGO28)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0198-3118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/08/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/08/2015
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0198) , manufacture(58443-0198) , label(58443-0198)

Revised: 1/2020
Document Id: 9c5acd24-5ce9-1835-e053-2a95a90a549e
Set id: 219d8726-16da-096e-e054-00144ff88e88
Version: 3
Effective Time: 20200117
 
Prime Enterprises Inc.