EVERYDAY SUNSCREEN WITH SUNFLOWER EXTRACT BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [TAYLOR JAMES LTD]

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  • EVERYDAY SUNSCREEN WITH SUNFLOWER EXTRACT BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [TAYLOR JAMES LTD]

EVERYDAY SUNSCREEN WITH SUNFLOWER EXTRACT BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [TAYLOR JAMES LTD]
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NDC 75936-210-01, 75936-210-02
Set ID 81b9fda2-bd55-1b90-e053-2991aa0a765a
Category HUMAN OTC DRUG LABEL
Packager TAYLOR JAMES LTD
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Avobenzone 3% Sunscreen

    Homosalate 10% Sunscreen

    Octisalate 5% 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 casused 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 gerenously and evenly 15 minutes before sun exsposure
    • 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 time in the sun, especially from 10 a.m.- 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Polyester-8, Acrylates Copolymer, Diisopropyl Sebacate, Glycerin, Isodecyl Neopentanoate, Isododecane, Lauryl Lactate, Cetyl Alcohol, Potassium Cetyl Phosphate, Brassica Campstris/Aleurites Fordi Oil Copolymer, Oryza Sativa (Rice) Bran Extract, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/ VP Copolymer, Hydroxyacetophenone, Sorbitan Olivate, Diethylhexyl Syringylidenemalonate, Aniba Roseodora (Rosewood) Wood Oil, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Ethyhexylglycerin, Eucaluptyus Globulus Leaf Oil, Ocimum Basilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Pentylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Xanthan Gum, Helianthus Annuus (sunflower) Extract, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Trisodium Ethylenediamine Disuccinate, Tocopherol, Allantoin, Rosmarinus Officinialis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride, Panthenol, Pentasodium Triphosphate, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    Everyday Sunscreen with Sunflower Extract

    Broad Spectrum SPF 30

    2.4 fl. oz. 71 ml

    everyday lotion 30 carton

    Everyday lotion 30

  • INGREDIENTS AND APPEARANCE
    EVERYDAY SUNSCREEN WITH SUNFLOWER EXTRACT BROAD SPECTRUM SPF 30 
    avobenzone, homosalate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    ROSEWOOD OIL (UNII: F2522O5L7B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    LEMON OIL (UNII: I9GRO824LL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    WATER (UNII: 059QF0KO0R)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    ISODODECANE (UNII: A8289P68Y2)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    RICE BRAN (UNII: R60QEP13IC)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    BEHENIC ACID (UNII: H390488X0A)  
    CETYL BEHENATE (UNII: WFM51TRO3E)  
    ISOSTEARYL STEARATE (UNII: E08UTG6X4W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-210-0171 mL in 1 BOTTLE; Type 0: Not a Combination Product02/12/2019
    2NDC:75936-210-03162 mL in 1 BOTTLE; Type 0: Not a Combination Product02/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/12/2019
    Labeler - TAYLOR JAMES LTD (033381850)
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