Label: SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN- titanium dioxide lotion/shampoo

  • NDC Code(s): 52915-030-29
  • 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 22, 2021

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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 occurs.

    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: 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, isoamyl laurate, coco-caprylate, calendula officinalis extract (calendula), 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, gardenia tahitensis flower extract, squalane, magnesium stearate, p-anisic acid, cymbopogon schoenanthus oil, allantoin, panthenol.

  • PRINCIPAL DISPLAY PANEL - 82 g Tube Label

    CALIF♥RNIA BABY®

    TRUSTED SINCE 1995

    everyday/year-round™

    30+
    SUNSCREEN LOTION
    HIGH PROTECTION
    GARDENIA & LEMONGRASS

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

    FOR BABIES, KIDS + ADULTS
    WITH SENSITIVE SKIN

    © 2018
    NET WT 82 g/2.9 oz.

    ALLERGY
    TESTED

    Principal Display Panel - 82 g Tube Label
  • INGREDIENTS AND APPEARANCE
    SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN 
    titanium dioxide lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52915-030
    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)  
    panthenol (UNII: WV9CM0O67Z)  
    gardenia taitensis flower (UNII: T0OCU8201Y)  
    cymbopogon schoenanthus oil (UNII: XE7K568ILO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52915-030-2982 g in 1 TUBE; Type 0: Not a Combination Product08/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/31/2015
    Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)
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