Label: FABULOUS FACE SPF 15- avobenzone, homosalate and oxybenzone lotion

  • NDC Code(s): 67038-105-50, 67038-105-51
  • Packager: Bliss World LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/12

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

  • Active Ingredients

    Drug Facts

    Active ingredients

    Avobenzone 3%   Homosalate 8%   Oxybenzone 3.5%

    Close
  • Purpose

    Purposes

    Sunscreen

    Close
  • Keep Out of Reach of Children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • Uses

    Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    Close
  • Warnings

    Warnings

    For external use only

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash or irritation develops and lasts .

    Close
  • Directions

    Directions

    • Apply liberally 30 minutes before sun exposure
    • Children under 6 months of age: ask a doctor
    • Reapply as needed or after towel drying, swimming or perspiring
    Close
  • Other information

    Other information

    Reports of serious side effects associated with use of the product can be sent to: 75 Varick St. 10th floor, New York, New York 10013

    Close
  • Inactive Ingredients

    Inactive ingredients

    water, PPG-3 benzyl ether myristate, butylene glycol, cyclopentasiloxane, cetyl alcohol, dimethicone, glyceryl stearate, diethylhexyl 2,6-naphthalate, lactobacillus/dipteryx odorata seed fermented filtrate, dimethicone crosspolymer, PEG-75 stearate, carbomer, glycerin, chlorphenesin, ceteth-20, steareth-20, 1,2-hexanediol, capryly glycol, sodium hydroxide, potassium sorbate, sodium benzoate, ascorbic acid polypeptide, sodium PCA, urea, helianthus annus (sunflower) seed oil, disodium EDTA, pantothenic acid/yeast polypeptide, xanthan gum, fragrance, zea mays (corn) oil, polyquaternium-51, trehalose, tocopherol/wheat polypeptides, saccharomyces/copper ferment, saccharomyces/iron ferment, saccharomyces/magnesium ferment, saccharomyces/silicon ferment, saccharomyces/zinc ferment, leuconostac/radish root ferment filtrate, sesamum indicum (sesame) seed oil, phenoxyethanol, macademia integrifolia seed oil, lecithin, litchi chinensis pericarp extract, olea europaea (olive) fruit oil, methylisothiazolinone, daucus carota sativa (carrot) root, retinyl palmitate, sodium hyaluronate, triacetin, tropolone, benzoic acid, lepidium sativum sprout extract, mica, titanium dioxide

    Close
  • Package Label

    bliss

    from our spa to your skin

    all skin types

    fabulous face lotion with spf 15

    lightweight, non-greasy formula

    delivers essential vitamins, minerals and omegas    illuminates skin with phytonutrients

    SPF 15 UVB UVA PA++

    50 mL/1.7 fl oz

    bliss Dist. Bliss   New York, NY 10013 USA  

    London MA3 600 UK    Made in USA - 1003-02270   blissworld.com

    Bliss Fab Face Label








    Close
  • INGREDIENTS AND APPEARANCE
    FABULOUS FACE  SPF 15
    avobenzone, homosalate, oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67038-105
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 1.75 g  in 50 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    DIPTERYX ODORATA SEED (UNII: D43A5L1U6L)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CETETH-20 (UNII: I835H2IHHX)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    UREA (UNII: 8W8T17847W)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PANTOTHENIC ACID (UNII: 19F5HK2737)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN OIL (UNII: 8470G57WFM)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 4:1) (UNII: X8Q92E1CPM)  
    TREHALOSE (UNII: B8WCK70T7I)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    YEAST (UNII: 3NY3SM6B8U)  
    WHEAT (UNII: 4J2I0SN84Y)  
    RADISH (UNII: EM5RP35463)  
    SESAME OIL (UNII: QX10HYY4QV)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    LITCHI FRUIT (UNII: Y5P61KP51E)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CARROT (UNII: L56Z1JK48B)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TRIACETIN (UNII: XHX3C3X673)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67038-105-50 15 mL in 1 TUBE
    2 NDC:67038-105-51 50 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 06/01/2011
    Labeler - Bliss World LLC (077427396)
    Registrant - Bliss World LLC (077427396)
    Close