DAILY DRIVER SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [EAI-JR 286, INC]

DAILY DRIVER SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [EAI-JR 286, INC]
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NDC 71014-013-01
Set ID 799e358f-f796-4c1c-e053-2991aa0a9fe4
Category HUMAN OTC DRUG LABEL
Packager Eai-jr 286, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Homosalate 5% Sunscreen

    Octisalate 5% Sunscreen

    Avobenzone 3% Sunscreen

    Octocrylene 2.7% Sunscreen

  • PURPOSE

    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
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    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

  • DOSAGE & ADMINISTRATION

    Directions

    Apply liberally and generously 15 minutes before sun exposure and at least
    every 2 hours.

    • 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 value of 15 or higher and other sun
    protection measures including: • limit your time in the sun, especially from 10
    a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses

    • Children under 6 months of age: ask a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Isododecane, Dimethicone, Glycerin, Tapioca starch, Pentylene Glycol, Cetearyl Alcohol, Polyurethane-34, Polysilicone-11, Isododecane, Coco-Caprylate/-Caprate, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Hydrolyzed Hibiscus Esculentes Extract, Butylene Glycol, SOdium Polyacrylate, Dextrin, Citrus Sinensis (Blood Orange) Fruit Extract, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Ethylhexyl Stearate, Xanthan Gum, Ammonium Acryloyldeimethyltaurate/VP Copolymer, Fragrance, Chlorphenesin, Aloe Barbadensis Leaf Juice, Sodium Citrate, Tocopheryl Acetate, Trideceth-6, Leuconostoc/Radish root ferment Filtrate, Disodium EDTA, Decyl Glucoside, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Aminomethyl Propanol

  • PRINCIPAL DISPLAY PANEL

    Daily Driver

    Sun Resistance & anti-aging

    Face and Body Lotion

    Broad Spectrum SPF 30

    Color: Untinted

    primary

    box

  • INGREDIENTS AND APPEARANCE
    DAILY DRIVER SUNSCREEN BROAD SPECTRUM SPF 30 
    homosalate, octisalate, avobenzone, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71014-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRUS SINENSIS WHOLE (UNII: 37673443KL)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    ISODODECANE (UNII: A8289P68Y2)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71014-013-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product11/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/02/2018
    Labeler - Eai-jr 286, Inc (827896718)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwest Cosmetic Laboratories LLC929572014manufacture(71014-013)

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