Label: SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS- titanium dioxide and zinc oxide stick
KIDS SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS- titanium dioxide and zinc oxide stick

  • NDC Code(s): 59062-1200-1, 59062-1200-2, 59062-2200-4
  • 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 June 8, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Titanium Dioxide 7.9%, Zinc Oxide 6.7%

  • 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 and evenly 15 minutes before sun exposure
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • this product is meant for targeted protection and small areas of exposed skin
    • for full protection use in conjunction with another sunscreen lotion or spray
    • 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
    • keep outer card for full drug facts
  • Inactive ingredients

    C12-15 alkyl benzoate, caprylic/capric triglyceride, beeswax1, copernicia cerifera (carnauba) wax1, neopentyl glycol diethylhexanoate, tribehenin, euphorbia cerifera (candelilla) wax, PPG-3 benzyl ether myristate, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, helianthus annuus (sunflower) seed wax, myristyl myristate, stearyl/octadodecyl citrate crosspolymer, simmondsia chinensis (jojoba) seed oil1, polyglyceryl-10 pentaoleate, jojoba esters, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (raspberry) seed oil, polyhydroxystearic acid, caprylyl glycol, ethylhexylglycerin, silica, alumina

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

    dist. by KAS direct, LLC
    Westbury, NY 11590

  • PRINCIPAL DISPLAY PANEL - 13 g Applicator Blister Pack

    babyganics®

    SPF 50 mineral sunscreen

    broad spectrum SPF 50

    pediatrician
    &
    dermatologist
    tested

    water
    resistant
    (80 minutes)

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

    NET WT 0.47 OZ (13 g)

    Principal Display Panel - 13 g Applicator Blister Pack
  • PRINCIPAL DISPLAY PANEL - 45.5 g Applicator Label

    50+
    SPF

    babyganics

    kids

    SPF 50+ sunscreen stick
    all mineral active ingredients

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

    formulated with: Titanium
    Dioxide, Zinc Oxide*

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

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

    Net. Wt. 1.6 OZ (45.5 g)

    040-17936-B01

    Principal Display Panel - 45.5 g Applicator Label
  • INGREDIENTS AND APPEARANCE
    SPF 50 PLUS SUNSCREEN   ALL MINERAL ACTIVE INGREDIENTS
    titanium dioxide and zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE79 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE67 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    Stearyl/Octyldodecyl Citrate Crosspolymer (UNII: PN88NW0KPK)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Polyglyceryl-10 Pentaoleate (UNII: BH1TF96DJC)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOMATO SEED OIL (UNII: 7N87T9C06T)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-1200-11 in 1 BLISTER PACK06/21/2013
    113 g in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:59062-1200-22 in 1 BLISTER PACK06/21/2013
    213 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35206/21/2013
    KIDS SPF 50 PLUS SUNSCREEN   ALL MINERAL ACTIVE INGREDIENTS
    titanium dioxide and zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-2200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE79 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE67 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    Stearyl/Octyldodecyl Citrate Crosspolymer (UNII: PN88NW0KPK)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Polyglyceryl-10 Pentaoleate (UNII: BH1TF96DJC)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOMATO SEED OIL (UNII: 7N87T9C06T)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-2200-445.5 g in 1 APPLICATOR; Type 0: Not a Combination Product06/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35206/21/2013
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
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