Label: FRESH SKIN ORGANICS- ab nat zinc lotion

  • Contains inactivated NDC Code(s)
    NDC Code(s):     58418-425-00, 58418-425-01, 58418-425-02, 58418-425-04, view more
    58418-425-05, 58418-425-08, 58418-425-09, 58418-425-12, 58418-425-16, 58418-425-28, 58418-425-34, 58418-425-55, 58418-425-64
  • Packager: Tropical Enterprises International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 8, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Zinc Oxide (18%)

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses: Our SPF formulas provide both UVA and UVB

    protection, and are infused with antioxidants and nutrients to help

    prevent sun damage while keepingthe skin well-hydrated.

  • WARNINGS

    WARNINGS:

    For external use only.

    Do not use on damaged or broken skin.

  • WHEN USING

    When using this product avoid contact with eyes.

    If contact with eyes occurs, flush with water to remove.

  • STOP USE

    Stop use and ask a doctor if irritation or rash develops

    and persists.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed,

    seek immediate medical attention or contact a Poison Control Center

    right away.

    For use on children under 6 months: consult a physician.

  • QUESTIONS

    Questions? Call 1-800-535-5053

  • PRINCIPAL DISPLAY PANEL

    30ml

  • INGREDIENTS AND APPEARANCE
    FRESH SKIN ORGANICS 
    ab nat zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-425
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.05 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    JOJOBA OIL (UNII: 724GKU717M)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    CAPRYLIC ACID (UNII: OBL58JN025)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    SQUALANE (UNII: GW89575KF9)  
    Product Characteristics
    Colorwhite (zinc lotion) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58418-425-0015 mL in 1 PACKET; Type 0: Not a Combination Product03/02/2020
    2NDC:58418-425-0515 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/02/2020
    3NDC:58418-425-0130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/02/2020
    4NDC:58418-425-0260 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/02/2020
    5NDC:58418-425-04120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/02/2020
    6NDC:58418-425-08240 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/02/2020
    7NDC:58418-425-09240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/02/2020
    8NDC:58418-425-16480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/02/2020
    9NDC:58418-425-12360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/02/2020
    10NDC:58418-425-641920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/02/2020
    11NDC:58418-425-34100.55 mL in 1 TUBE; Type 0: Not a Combination Product03/01/2020
    12NDC:58418-425-283840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/02/2020
    13NDC:58418-425-55211200 mL in 1 DRUM; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2020
    Labeler - Tropical Enterprises International, Inc. (091986179)
    Registrant - Tropical Enterprises International, Inc. (091986179)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Enterprises International, Inc.091986179repack(58418-425)
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