Label: MEANINGFUL BEAUTY BB BROAD SPECTRUM SPF 15 (LIGHT, MEDIUM, DARK)- octinoxate, octisalate, and oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 4, 2016

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 7.5%
    Octisalate 5.0%
    Oxybenzone 3.0%

  • 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 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

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 40 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 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
    • children under 6 months: Ask a doctor
  • Inactive ingredients

    water, ethylhexyl palmitate, isostearyl neopentanoate, propylene glycol, stearic acid, propylene glycol stearate SE, glycerin, talc, dimethicone, cetyl alcohol, magnesium ascorbyl phosphate, tocopherol, ascorbyl palmitate, sodium hyaluronate, lecithin, xanthan gum, sorbitan stearate, magnesium aluminum silicate, acrylates/C10-30 alkyl acrylate crosspolymer, ammonium polyacrylate, triethanolamine, disodium EDTA, phenoxyethanol, methylparaben, propylparaben, butylparaben, methylisothiazolinone. may contain (+/-) : iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891)

  • Other information

    • protect this product from excessive heat and direct sun
  • Questions or comments?

    Within US 1-800-950-4465

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Meaningful Beauty®
    Santa Monica, CA 90405

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Box

    Meaningful Beauty®
    Cindy Crawford

    BB Crème
    Broad Spectrum SPF 15

    • Broad Spectrum SPF 15
      helps protect the skin against
      the sun's harmful rays
    • Designed to help moisturize
      the skin
    • Designed to help smooth the
      appearance of the skin
    • Dermatologist-tested
    • Non-comedogenic

    1.7 FL OZ/50mL

    Principal Display Panel - 50 mL Tube Box
  • INGREDIENTS AND APPEARANCE
    MEANINGFUL BEAUTY BB BROAD SPECTRUM SPF 15 (LIGHT, MEDIUM, DARK) 
    octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70605-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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) OXYBENZONE3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TALC (UNII: 7SEV7J4R1U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    PROPYLENE GLYCOL MONOPALMITOSTEARATE (UNII: F76354LMGR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70605-008-171 in 1 BOX04/30/2016
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/30/2016
    Labeler - Guthy-Renker LLC (948861877)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!