Label: THE GOOD STUFF AFTERSHAVE SPF 15- avobenzone, octocrylene, and octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0198-3 - Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 17, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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 spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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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
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INGREDIENTS AND APPEARANCE
THE GOOD STUFF AFTERSHAVE SPF 15
avobenzone, octocrylene, and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0198 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 18.5 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0198-3 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/08/2015 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0198) , manufacture(58443-0198) , label(58443-0198)
