FRESH BLACK TEA AGE-DELAY BROAD SPECTRUM SUNSCREEN SPF 20 (AVOBENZONE, OCTINOXATE, OXYBENZONE) LOTION [FRESH, INC.]

FRESH BLACK TEA AGE-DELAY BROAD SPECTRUM SUNSCREEN SPF 20 (AVOBENZONE, OCTINOXATE, OXYBENZONE) LOTION [FRESH, INC.]
PDF | XML

NDC 42406-009-00
Set ID 3e42b437-756e-4216-afb8-3cc43d4e4295
Category HUMAN OTC DRUG LABEL
Packager Fresh, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Fresh Black Tea Age-Delay Lotion Broad Spectrum Sunscreen SPF 20


  • Active Ingredients

    Avobenzone 1.80%
    Octinoxate 7.49%
    Oxybenzone 2.40%

    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.

  • Directions

    For sunscreen use:

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • 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 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-sleeve shirts, pants, hats and sunglasses
  • Other Information

    Protect this product in container from excessive heat and direct sun

  • Inactive Ingredients


    Aqua (Water), Isostearyl Neopentanoate, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycine Soja (Soybean) Oil, Saccharomyces Ferment Filtrate, Camellia Sinensis Leaf Extract, Rubus Fruticosus (Blackberry) Leaf Extract, Litchi Chinensis Seed Extract, Adenosine, Tocopherol, Hydrogenated Lecithin, Parfum (Fragrance), Ethylhexyl Palmitate, Diethylhexyl Syringylidenemalonate, Potassium Sorbate, Sodium Benzoate, Butylene Glycol, Trisodium EDTA, Xanthan Gum, Sodium Hyaluronate, Maltodextrin, Hydrogenated Phosphatidylcholine, Polysorbate 60, Sorbitan Isostearate, BHT, Caprylic/Capric Triglyceride, Hydroxyethylcellulose, Sodium Citrate, Citric Acid, Biotin, Phenoxyethanol, Linalool (08235/Z)

  • Questions or Comments?

    Call toll free 1(800)FRESH-20
    Monday-Friday (9a.m. to 5p.m. EST )

  • Fresh Black Tea Age-Delay Lotion Broad Spectrum Sunscreen SPF 20 50ml (42406-009-00)

    l1

    l2

  • INGREDIENTS AND APPEARANCE
    FRESH BLACK TEA AGE-DELAY BROAD SPECTRUM SUNSCREEN SPF 20 
    avobenzone, octinoxate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42406-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE18 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE74.9 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE24 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    RUBUS FRUTICOSUS LEAF (UNII: YQ2S06L8S9)  
    LITCHI CHINENSIS SEED (UNII: 9294024N9Q)  
    ADENOSINE (UNII: K72T3FS567)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BIOTIN (UNII: 6SO6U10H04)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42406-009-001 in 1 BOX02/06/2014
    150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/06/2014
    Labeler - Fresh, Inc. (021403729)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Laboratories, LLC.068351753manufacture(42406-009)

Related Drugs