Label: SKINCARE LDEL RETINOL DAY BROAD SPECTRUM SPF 20- avobenzone, homosalate, oxybenzone, and octinoxate cream

  • 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 November 11, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients:

    Avobenzone 2%

    Homosalate 3%

    Octinoxate 7.5%

    Oxybenzone 5%

  • Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    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 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 hours.
    • Children under 6 months: Ask a doctor.
    • Apply to all skin exposed to the sun.

    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 am to 2 pm.
    • Wear long-sleeve shirts, pants, hat and sunglasses.
  • Other information:

    • Protect the product in this container from excessive heat and direct sunlight.
    • You may report a serious adverse reaction from using this product to Beauty Solutions, Ltd. 411 Fifth Avenue, New York, NY 10016.
  • Inactive ingredients:

    Water, Glycerin, Cetearyl Alcohol, Petrolatum, Argania Spinosa Kernel Oil, Glyceryl Stearate, Tocopheryl Acetate, Phenoxyethanol, Retinyl Palmitate, PEG-40 Stearate, PEG-8 Stearate, Stearic Acid, Fragrance (Parfum), Amyl Cinnamal, Benzyl Salicylate, Citronellol, Coumarin, Eugenol, Alpha-isomethyl Ionone, Geraniol, Hexyl Cinnamal, Butylphenyl Methylpropional, Linalool, Methylparaben, Carbomer, BHT, Silk Amino Acids, Sodium Hydroxide, Propylparaben, Ascorbyl Palmitate, Chitosan PCA, Xanthan Gum, Ethylparaben, Bisabolol, Disodium EDTA.

  • Principal Display Panel - 63g Jar Carton

    Skincare LdeL Cosmetics®
    RETINOL

    VITAMIN ENRICHED

    Day Cream
    Broad Spectrum SPF 20

    Daily Moisturizing Cream
    to Nourish and Protect

    Net Wt. 63 g 2.25 Oz.

    Principal Display Panel - 63g Jar Carton
  • INGREDIENTS AND APPEARANCE
    SKINCARE LDEL RETINOL   DAY BROAD SPECTRUM SPF 20
    avobenzone, homosalate, oxybenzone, and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51117-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 20 mg  in 1 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 30 mg  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 50 mg  in 1 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Argan Oil (UNII: 4V59G5UW9X)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Levomenol (UNII: 24WE03BX2T)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Ethylparaben (UNII: 14255EXE39)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Peg-40 Stearate (UNII: ECU18C66Q7)  
    Peg-8 Stearate (UNII: 2P9L47VI5E)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Amino Acids, Silk (UNII: V0L00EX1IA)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    .Alpha.-Amylcinnamaldehyde (UNII: WC51CA3418)  
    Benzyl Salicylate (UNII: WAO5MNK9TU)  
    .Beta.-Citronellol, (R)- (UNII: P01OUT964K)  
    Coumarin (UNII: A4VZ22K1WT)  
    Eugenol (UNII: 3T8H1794QW)  
    Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)  
    Geraniol (UNII: L837108USY)  
    .Alpha.-Hexylcinnamaldehyde (UNII: 7X6O37OK2I)  
    Butylphenyl Methylpropional (UNII: T7540GJV69)  
    Linalool, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51117-001-011 in 1 CARTON09/05/2012
    163 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:51117-001-021 in 1 CARTON09/05/2012
    250 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/05/2012
    Labeler - Beauty Solutions, Ltd. (184041981)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhytogenX, Inc.624386772MANUFACTURE(51117-001)
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