Label: BABYGANICS SPF 50 PLUS SUNSCREEN- zinc oxide, octisalate, and octocrylene spray

  • NDC Code(s): 59062-0120-1
  • 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 January 15, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Zinc Oxide 11.20%, Octocrylene 6.0%, Octisalate 5.0%

  • 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.

    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 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • do not spray directly into face. Spray on hands then apply to face.
    • 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-sleeved shirts, pants, hats, and sunglasses
  • Other information

    protect this product from excessive heat and direct sun

  • Inactive ingredients

    water, caprylic/capric triglyceride, glycerin, butyloctyl salicylate, stearyl/octyldodecyl citrate crosspolymer, aloe barbadensis leaf juice, glyceryl stearate, polyglyceryl-6 polyricinoleate, helianthus annuus (sunflower) seed oil, solanum lycopersicum (tomato) seed oil, lecithin, polysorbate 60, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil organic, rubus idaeus (raspberry) seed oil, squalane, xanthan gum, polysorbate 80, phenethyl alcohol, glyceryl caprylate, lithium magnesium sodium silicate, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, sorbitan isostearate, citric acid

  • SPL UNCLASSIFIED SECTION

    dist. by KAS Direct, LLC.
    Westbury, NY 11590

  • PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

    50+
    SPF

    tear
    free

    water
    resistant

    babyganics

    SPF 50+
    sunscreen
    spray

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

    formulated with: Zinc Oxide,
    Octocrylene, Octisalate*

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

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

    6 FL OZ (177 mL)

    040-12078-B02

    PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BABYGANICS SPF 50 PLUS SUNSCREEN 
    zinc oxide, octisalate, and octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-0120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE112 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    LAPONITE (UNII: D703131383)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SQUALANE (UNII: GW89575KF9)  
    TOMATO SEED OIL (UNII: 7N87T9C06T)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-0120-1177 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35207/01/2019
    Labeler - KAS Direct LLC dba Babyganics (002764605)
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