Label: DAYLOGIC BABY SPF 60- titanium dioxide, zinc oxide lotion

  • 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 March 8, 2016

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Titanium Dioxide  4.9%, Zinc Oxide 4.7%

  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

    •    May stain some fabrics

  • 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

    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 of 15 or higher and other protection measures including:

    •    limit time in the sun, especially from 10 a.m. to 2 p.m.

    •    wear long-sleeved shirts, pants, hats, and sunglasses

    •    children under 6 months: Ask a doctor

  • Inactive Ingredients

    Water, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Phenethyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Cyclopentasiloxane, C30-38 Olefin/Isopropyl  aleate/MA Copolymer, Cyclohexasiloxane, Ethylhexyl Methoxycrylene, Ozokerite, PEG-8, Sodium Chloride, Alumina, Phenoxyethanol, Caprylyl Glycol, Dimethicone, Glycerin, Methicone, Sodium Citrate, Disodium EDTA, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice Powder, Panthenol.

  • Other Information

    •    protect this product from excessive heat and direct sun

    •    protect from freezing

  • Principle Display Label

    NDC:  11822-3150-2

    daylogic

    baby

    SUNSCREEN LOTION

    BROAD SPECTRUM SPF 60+

    UVA/UVB Protection

    Water Resistant (80 Minutes)

    Hypoallergenc

    60+

    3 FL OZ (88ml)

    LABEL

  • INGREDIENTS AND APPEARANCE
    DAYLOGIC BABY SPF 60 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.9 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-3150-288 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/08/2016
    Labeler - Rite Aid (014578892)