DailyMed - ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN (2025)

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• NDC Code(s): 72330-512-01
• Packager: fmg Co.Ltd

• Category: HUMAN OTC DRUG LABEL
• DEA Schedule: None

Drug Label Information

Updated January 1, 2025

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• ACTIVE INGREDIENTS

  Zinc Oxide 15.52%

• 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

• DO NOT USE
  • Do not use​on damaged or broken skin
• WHEN USING
  • When using this productkeep out of eyes. Rinse with water to remove.
• STOP USE
  • Stop use and ask a doctor ifrash occurs
• KEEP OUT OF REACH OF CHILDREN
  • Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
• DIRECTIONS

  For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • children under 6 months of age: ask a doctor
  • 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 with a Broad Spectrum SPF value 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
• OTHER INFORMATION
  • protect the product in this container from excessive heat and direct sun
  • the product may stain certain types of fabrics
• INACTIVE INGREDIENTS

  WATER

• QUESTIONS?

  1-800-FOR-AVON

• SPL UNCLASSIFIED SECTION

  + Hypoallergenic+ Dermatologist-tested+ Suitable for Sensitive Skin+ Fragrance-Free + PABA-Free + Alcohol-Free+ Water-resistant (40 minutes)+ Reef-friendly

  To order, contact your Avon Indenpendent Sales Representative or call: 1-800-FOR-AVON

  www.avon.com

  MADE IN KOREA DISTR. THE AVON COMPANY, NEW YORK, NY 10006 ©2023 THE AVON COMPANY

• PRINCIPAL DISPLAY PANEL

  ISA KNOX

  ANEW

  SOLAIRE

  50 SPF

  EVERYDAY MINERAL FACE

  PROTECTION CREAM BROAD SPECTRUM SPF 50 SUNSCREEN

  WATER-RESISTANT (40 MINUTES)

  50 ml/1.7 fl.oz.

  

  

• INGREDIENTS AND APPEARANCE

  ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENzinc oxide cream

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72330-512 Route of Administration TOPICAL

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15.52g in50mL

  Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72330-512-01 2 in 1 BOX 07/14/2023 1 50 mL in 1 TUBE; Type 0: Not a Combination Product

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/14/2023

  Labeler -fmg Co.Ltd(690188305)

  Registrant -LG H&H Co., Ltd. (688276187)

  Establishment
  Name	Address	ID/FEI	Business Operations
  fmg Co.Ltd		690188305	manufacture(72330-512)

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ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN- zinc oxide cream

Number of versions: 2

RxNorm

ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN- zinc oxide cream

Under Review - Editing is pending for RxNorm. If in scope, these drugs will include RxNorm normal forms when editing is complete.

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NDC Codes

ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN- zinc oxide cream

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.