Label: LAURA MERCIER FOUNDATION PRIMER PROTECT BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, octinoxate, octocrylene, and oxybenzone cream

  • NDC Code(s): 58411-368-60
  • Packager: Laura Mercier Cosmetics
  • 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 January 2, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone (3.0%), Octinoxate (7.3%), Octocrylene (3.0%), Oxybenzone (2.0%)

  • 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • For sunscreen use:
      • apply liberally 15 minutes before sun exposure
      • use a water resistant sunscreen if swimming or sweating
      • reapply 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 value 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-sleeved shirts, pants, hats, and sunglasses
    • Children under 6 months of age: Ask a doctor
  • Other information

    Protect the product in this container from excessive heat and direct sun.

  • Inactive ingredients

    Water, Glycerin, Isohexadecane, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Xanthan Gum, Polysorbate 80, Ethylhexylglycerin, Tocopherol, Disodium EDTA, PEG-8, Ascorbyl Palmitate, Citric Acid, Ascorbic Acid. May Contain (+/-): Yellow 5, Red 6.

  • Questions or comments?

    Call 1-888-637-2437, M – F 9am – 5pm CST.

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

    laura mercier

    FOUNDATION PRIMER
    PROTECT

    BROAD SPECTRUM
    SPF 30 SUNSCREEN

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    LAURA MERCIER FOUNDATION PRIMER PROTECT   BROAD SPECTRUM SPF 30 SUNSCREEN
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-368
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1500 mg  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3650 mg  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1500 mg  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1000 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-368-601 in 1 CARTON04/11/2014
    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 NOT FINALpart35204/11/2014
    Labeler - Laura Mercier Cosmetics (193691821)