Label: SPF30 CALENDULA SUNSCREEN- titanium dioxide lotion

  • NDC Code(s): 52915-067-29
  • Packager: ORGANIC & SUSTAINABLE BEAUTY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 6, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Titanium Dioxide 12%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

    • higher SPF gives more sunburn protection
    • retains SPF after 80 minutes of activity in the water
  • Warnings

    For external use only

    Do not use: on damaged or broken skin.

    Stop use and ask a doctor if

    • rash or irritation develops and lasts.

    When using this product keep out of eyes. Rinse with water to remove.

    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
    • 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 the product in this container from excessive heat and direct sunlight. Report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016

  • Inactive ingredients

    Water, calendula officinalis extract (calendula), isoamyl laurate, coco-caprylate, viola tricolor extract (pansy), polyglyceryl-2 dipolyhydroxystearate, euphorbia cerifera (candelilla) wax, glyceryl starch, carthamus tinctorius (safflower) oleosomes, polyglyceryl-3 diisostearate, levulinic acid, glycerin, tapioca starch, rosmarinus officinalis (rosemary) leaf extract, cocos nucifera (coconut) oil, squalane, magnesium stearate, p-anisic acid, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, allantoin, panthenol.

  • PRINCIPAL DISPLAY PANEL - 82 g Tube Label

    CALIF♥RNIA BABY®
    TRUSTED SINCE 1995

    calendula™

    30+
    SUNSCREEN LOTION

    HIGH PROTECTION

    SUPER GENTLE & SOOTHING

    BROAD SPECTRUM
    SPF 30+ SUNSCREEN
    WATER RESISTANT (80 MINUTES)

    FOR BABIES, KIDS + ADULTS
    WITH SENSITIVE SKIN

    ALLERGY
    TESTED

    © 2018
    NET WT 82 g/2.9 oz.

    Principal Display Panel - 82 g Tube Label
  • INGREDIENTS AND APPEARANCE
    SPF30 CALENDULA SUNSCREEN 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52915-067
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE120 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    isoamyl laurate (UNII: M1SLX00M3M)  
    coco-caprylate (UNII: 4828G836N6)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    VIOLA TRICOLOR WHOLE (UNII: 9Q24RAI43V)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    STARCH, RICE (UNII: 4DGK8B7I3S)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
    levulinic acid (UNII: RYX5QG61EI)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    ROSEMARY (UNII: IJ67X351P9)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    squalane (UNII: GW89575KF9)  
    magnesium stearate (UNII: 70097M6I30)  
    p-anisic acid (UNII: 4SB6Y7DMM3)  
    allantoin (UNII: 344S277G0Z)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    panthenol (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52915-067-2982 g in 1 TUBE; Type 0: Not a Combination Product12/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/01/2012
    Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)
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