Label: SPF30 SUMMER BLEND SUNSCREEN- titanium dioxide lotion/shampoo

  • NDC Code(s): 52915-040-29
  • 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 4, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Titanium Dioxide 12%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • 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 30 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, c12-15 alkyl benzoate, coco-caprylate, glycerin, polyhydroxystearic acid, caprylic/capric triglyceride, polyglyceryl-2 dipolyhydroxystearate, candelilla cera, cocos nucifera (coconut) oil, tapioca starch, polyglyceryl-3 diisostearate, rosmarinus officinalis (rosemary) leaf extract, squalane, allantoin, panthenol, magnesium stearate, sodium levulinate, cymbopogon nardus oil, cymbopogon schoenanthus oil, cedrus atlantica wood oil, caprylhydroxamic acid, glyceryl caprylate.

  • PRINCIPAL DISPLAY PANEL - 82 g Tube Label

    CALIFORNIA BABY®
    TRUSTED SINCE 1995

    summer blend™

    30+
    SUNSCREEN LOTION

    HIGH PROTECTION

    GET OUTDOORSY WITH IT

    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.

    BLENDED, MANUFACTURED & PACKAGED IN OUR FDA REGISTERED & CERTIFIED ORGANIC U.S.A. FACILITY

    Principal Display Panel - 82 g Tube Label
  • INGREDIENTS AND APPEARANCE
    SPF30 SUMMER BLEND SUNSCREEN 
    titanium dioxide lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52915-040
    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)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    carthamus tinctorius seed oleosomes (UNII: 9S60Q72309)  
    coco-caprylate (UNII: 4828G836N6)  
    glycerin (UNII: PDC6A3C0OX)  
    polyhydroxystearic acid (2300 MW) (UNII: YXH47AOU0F)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    candelilla wax (UNII: WL0328HX19)  
    coconut oil (UNII: Q9L0O73W7L)  
    starch, tapioca (UNII: 24SC3U704I)  
    polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
    rosemary (UNII: IJ67X351P9)  
    squalane (UNII: GW89575KF9)  
    allantoin (UNII: 344S277G0Z)  
    panthenol (UNII: WV9CM0O67Z)  
    magnesium stearate (UNII: 70097M6I30)  
    levulinic acid (UNII: RYX5QG61EI)  
    citronella oil (UNII: QYO8Q067D0)  
    cymbopogon schoenanthus oil (UNII: XE7K568ILO)  
    cedrus atlantica bark oil (UNII: ZX5QRE4U60)  
    caprylhydroxamic acid (UNII: UPY805K99W)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52915-040-2982 g in 1 TUBE; Type 0: Not a Combination Product04/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/01/2010
    Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)
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