Label: MEANINGFUL BEAUTY CINDY CRAWFORD MAINTENANCE 1 DAILY MOISTURE SPF 8- octinoxate and avobenzone lotion

  • 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 September 1, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Octinoxate5.0%
    Avobenzone3.0%
  • Uses

    helps prevent sunburn. Sunscreen gives more sunburn protection.

  • 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 or lasts.

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

    Sun alert

    Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

  • Directions

    Use in the morning and before sun exposure. Smooth onto face after cleansing. Children under 6 months of age: ask a doctor.

  • Inactive Ingredients

    Water (Aqua), Glycerin, Ascorbyl Methylsilanol Pectinate, Propylene Glycol, Glyceryl Stearate, Acacia Senegal Extract, Achillea Millefolium Extract, Arctostaphylos Uva Ursi Leaf Extract, Cucumis Melo (Melon) Fruit Extract, Magnesium Ascorbyl Phosphate, Dipotassium Glycyrrhizate, Cholesterol, Lecithin, Hydrogenated Vegetable Oil, Caprylic/Capric Triglyceride, Sorbitol, Glycol Stearate, PEG-6 Stearate, PEG-32 Stearate, PEG-75 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Sodium Sulfite, Sodium Bisulfite, BHT, Sodium Hydroxide, Disodium EDTA, Tetrasodium EDTA, Fragrance (Parfum), Benzyl Benzoate, Benzyl Salicylate, Citronellol, Benzoic Acid, Butylparaben, Chlorphenesin, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sodium Methylparaben

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Guthy-Renker® (UK) Ltd.
    Covent Garden,
    London WC2E 8AA
    0800 320 504

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Box

    Meaningful Beauty®
    Cindy Crawford

    Maintenance 1

    Daily Moisture
    SPF 8 UVA/UVB

    .5 FL OZ/15mL e

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    MEANINGFUL BEAUTY CINDY CRAWFORD MAINTENANCE 1 DAILY MOISTURE SPF 8 
    octinoxate and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70605-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 mg  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    SODIUM BISULFITE (UNII: TZX5469Z6I)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70605-019-0615 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/30/2016
    2NDC:70605-019-461 in 1 BOX04/30/2016
    215 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:70605-019-1230 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/30/2016
    4NDC:70605-019-721 in 1 BOX04/30/2016
    430 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 FINALpart35204/30/2016
    Labeler - Guthy-Renker LLC (948861877)