Label: MEANINGFUL BEAUTY CINDY CRAWFORD SKIN BRIGHTENING DECOLLETE AND NECK TREATMENT SPF 15- avobenzone, octinoxate, octisalate, and oxybenzone cream

  • 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 April 1, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Fact Label

  • Active ingredient

    Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 5.0%

  • 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 aging caused by the sun.
  • Warnings

    For external use only.

    Do not use on damage or broken skin.

    When using this product 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

    • apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hrs.
    • children under 6 months, ask a doctor.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer early 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
  • Inactive ingredients

    Water, Neopentyl Glycol Diheptanoate, Dicaprylyl Carbonate, Cetearyl Alcohol, Butylene Glycol, Glycerin, PEG-40 Stearate, PEG-100 Stearate, Glyceryl Stearate, Dimethicone, Cucumis Melo (Melon) Fruit Extract, Arctostaphylos Uva Ursi Leaf Extract, Ascorbyl Methylsilanol Pectinate, Magnesium Ascorbyl Phosphate, Tetrapeptide-21, Biosaccharide Gum-1, Dipotassium Glycyrrhizate, Caprylyl Glycol, Hydrogenated Vegetable Oil, Alcohol, Hydrogenated Lecithin, Hydrogenated Phosphatidylcholine, Cholesterol, Ethylhexylglycerin, Polysorbate 60, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Steareth-20, Disodium EDTA, Potassium Sorbate, Sodium Hydroxide, Chlorphenesin, Phenoxyethanol, Fragrance.

  • Questions or comments?

    Within US 1-800-927-0047

  • SPL UNCLASSIFIED SECTION

    Distributed by: Meaningful Beauty®
    100 N. Sepulveda Blvd., El Segundo, CA 90245

  • PRINCIPAL DISPLAY PANEL - 120 mL Tube Label

    Meaningful Beauty® Cindy Crawford

    Skin Brightening Décolleté and Neck Treatment Broad Spectrum Sunscreen SPF 15

    120 mL/4 FL OZ

    PRINCIPAL DISPLAY PANEL - 120 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    MEANINGFUL BEAUTY CINDY CRAWFORD   SKIN BRIGHTENING DECOLLETE AND NECK TREATMENT SPF 15
    avobenzone, octinoxate, octisalate, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70605-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MUSKMELON (UNII: ZV095H5633)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    TETRAPEPTIDE-21 (UNII: 179JUC43HU)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALCOHOL (UNII: 3K9958V90M)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70605-006-531 in 1 BOX04/30/201612/31/2021
    150 mL in 1 JAR; Type 0: Not a Combination Product
    2NDC:70605-006-5750 mL in 1 TUBE; Type 0: Not a Combination Product04/30/2016
    3NDC:70605-006-8920 mL in 1 TUBE; Type 0: Not a Combination Product04/30/2016
    4NDC:70605-006-41120 mL in 1 TUBE; Type 0: Not a Combination Product03/03/201712/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/30/2016
    Labeler - Guthy-Renker LLC (948861877)