Label: AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF50 EARTHWELL ZINC TECHNOLOGY, REEF SAFE- zinc oxide lotion

  • NDC Code(s): 71942-102-01, 71942-102-04
  • Packager: Amavara, 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 April 16, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Zinc Oxide 22.5%

  • 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. Retains SPF after 80 minutes activity in the water, sweating or perspiring. Provides high protection against sunburn.

  • 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 or iritation develops and lasts.

    Keep out of reach of children

    • If Product is swallowed get medical help or contact a Poison Control Center right away.
  • Directions

    Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours

    • Children under 6 months of age, ask doctor
    • Reapply :
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least after 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 your 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.

  • Inactive Ingredients

    Water, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Polyglyceryl-3 Sorbityl Linseedate, Dimethicone, Caprylic/Capric Triglyceride, Mica, Cetyl Dimethicone, Silica, Polyhydroxystearic Acid, Phenyl Caprylic/Capric Triglyceride , Silica, Phenyl Trimethicone, Sodium Chloride, Hydroxyacetophenone, Iron Oxides, CI 77492, Disteardimonium Hectorite, 1,2 Hexanediol , Caprylyl Glycol,Polymethylmethacrylate, Tocopheryl Acetate, Iron Oxides (CI 77499, CI 77491, CI 77492), Glycerin, Bisabolol, Triethyl Citrate, Acrylates/Dimethicone Copolymer, Benzylidene Dimethoxydimethylindanone, Iron Oxides, Cerium Oxide, Aluminum Oxide, Zingiber Officinale (Ginger) Root Extract

  • PRINCIPAL DISPLAY PANEL - 49 mL Tube Label

    AMAVARA®

    REEF SAFE

    SPF 50

    + EarthWell® Zinc Technology
    Tinted Mineral Sunscreen

    Safe for Sensitive Skin
    Broad Spectrum SPF 50
    Water Resistant (80 Minutes)

    1.65 FL. OZ. / 49 mL

    Reef Safe

    Cruelty Free

    Child Friendly

    Dry Grip

    PRINCIPAL DISPLAY PANEL - 49 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF50   EARTHWELL ZINC TECHNOLOGY, REEF SAFE
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71942-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE225 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GINGER (UNII: C5529G5JPQ)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICA (UNII: V8A1AW0880)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    WATER (UNII: 059QF0KO0R)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CERIC OXIDE (UNII: 619G5K328Y)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71942-102-0170 mL in 1 BOX; Type 0: Not a Combination Product02/10/2018
    2NDC:71942-102-0449 mL in 1 TUBE; Type 0: Not a Combination Product04/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/10/2018
    Labeler - Amavara, Inc (079636282)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwest Cosmetic Laboratories LLC929572014manufacture(71942-102)