Label: KIDS SPF 50PLUS SUNSCREEN CONTINUOUS- zinc oxide and octisalate spray

  • NDC Code(s): 59062-0175-2, 59062-0175-6
  • Packager: KAS Direct LLC dba BabyGanics
  • 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 July 23, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octisalate 5.0%, Zinc oxide 15.0%

  • 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.
    • keep away from face to avoid breathing it
    • do not puncture or incinerate. Contents under pressure.
    • do not store at temperatures above 120° F

    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

    • spray liberally and spread evenly by hand 15 minutes before sun exposure
    • hold can 4-6 inches away from the skin to apply
    • do not spray directly into face. Spray into hands then apply to face.
    • do not apply in windy conditions
    • use in a well-ventilated area
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • children under 6 months of age: ask a doctor
    • 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-sleeve shirts, pants, hats, and sunglasses
  • Other information

    • protect this product from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces
  • Inactive ingredients

    water, butyloctyl salicylate, C30-38 olefin/isopropyl maleate/MA copolymer, bentonite, caprylic/capric triglyceride, glycerin, olive oil polyglyceryl-6 esters, sodium stearoyl lactylate, cetearyl alcohol, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil 1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil 1, rubus idaeus (red raspberry) seed oil, phenethyl alcohol, glyceryl caprylate, xanthan gum, tocopherol

    1
    Certified Organic Ingredient. Unless otherwise specified product not labeled as organic
  • SPL UNCLASSIFIED SECTION

    dist. by KAS direct, LLC
    San Francisco, CA 94111

  • PRINCIPAL DISPLAY PANEL - 170 g Can Label

    new!

    50+
    SPF

    babyganics

    kids

    SPF 50+ sunscreen
    continuous spray

    broad spectrum SPF 50+
    UVA + UVB protection • non-allergenic
    water & sweat resistant (80 minutes)
    dermatologist tested

    formulated with: Zinc Oxide,
    Octisalate*

    formulated without: Oxybenzone
    Octinoxate • nano-particles • PABA
    phthalates • parabens • fragrances

    Discover which of our ingredients
    are Certified Organic on back panel.

    NET WT 6 OZ (170 g)

    PRINCIPAL DISPLAY PANEL - 170 g Can Label
  • INGREDIENTS AND APPEARANCE
    KIDS SPF 50PLUS SUNSCREEN CONTINUOUS 
    zinc oxide and octisalate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-0175
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE150 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENTONITE (UNII: A3N5ZCN45C)  
    Glycerin (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOPROPYL MALEATE (UNII: M86R5J916V)  
    MALEIC ANHYDRIDE (UNII: V5877ZJZ25)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)  
    C30-38 OLEFIN (UNII: 04DAD0KDZ0)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOMATO SEED OIL (UNII: 7N87T9C06T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-0175-6170 g in 1 CAN; Type 0: Not a Combination Product12/15/2018
    2NDC:59062-0175-22 in 1 CELLO PACK12/15/2018
    2170 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/15/2018
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
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