Label: ABC ARBONNE BABY CARE SUNSCREEN BROAD SPECTRUM SPF 30 WATER-RESISTANT (40 MINUTES)- zinc oxide lotion

  • NDC Code(s): 42508-332-02
  • Packager: Arbonne International, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide 14.4%

  • 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 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 swallowed, get medical help or contact a Poison Control Center right away.

  • 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 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
    • children under 6 months of age: ask a doctor
  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    water, C12-15 alkyl benzoate, caprylic/capric triglyceride, coco-caprylate, polyglyceryl-2 dipolyhydroxystearate, dicaprylyl carbonate, polyglyceryl-4 isostearate, cetyl dimethicone, glycerin, copernicia cerifera (carnauba) wax, cetyl alcohol, euphorbia cerifera (candelilla) wax, tapioca starch, calendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, aloe barbadensis leaf juice, triethoxycaprylylsilane, tocopheryl acetate, magnesium sulfate, sodium chloride, silica dimethyl silylate, stearic acid, chlorphenesin, phenoxyethanol.

  • Questions or comments?

    1.800.272.6663

    Monday–Friday 6 a.m.–6 p.m. Pacific time

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Arbonne International, LLC
    Greenwood, IN 46143 USA

  • PRINCIPAL DISPLAY PANEL - 177 mL Tube Carton

    ABC
    ARBONNE BABY CARE®

    SUNSCREEN
    BROAD SPECTRUM SPF 30

    WATER-RESISTANT
    (40 Minutes)

    6 fl. oz./177 mL

    PRINCIPAL DISPLAY PANEL - 177 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    ABC ARBONNE BABY CARE SUNSCREEN BROAD SPECTRUM SPF 30 WATER-RESISTANT (40 MINUTES) 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42508-332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE144 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42508-332-021 in 1 CARTON06/30/2023
    1177 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02006/30/2023
    Labeler - Arbonne International, LLC (961643454)