Label: RECLAIM REVOLUTIONARY ANTI-AGING DAY SPF15- octinoxate, octisalate, and oxybenzone cream

  • NDC Code(s): 70605-042-07, 70605-042-15, 70605-042-43
  • Packager: Guthy-Renker LLC
  • 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 8, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Fact Label

  • Active ingredient

    Octinoxate 7.5%
    Octisalate 5.0%
    Oxybenzone 3.0%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn not skin cancer or early skin aging.

    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 2 hours
    • Children under 6 months: Ask a doctor.
  • Inactive ingredients

    Water, Octyldodecyl Neopentanoate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, PEG-8/SMDI Copolymer, Dipalmitoyl Hydroxyproline, Glycerin, Acetyl Hexapeptide-8, Sodium Hyaluronate, Ahnfeltia Concinna Extract, Glycosaminoglycans, Cucumis Melo (Melon) Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Vitis Vinifera (Grape) Leaf Extract, Iris Florentina Extract, Hibiscus Abelmoschuus Extract, Tricaprin, Dimethicone, Butylene Glycol, Cetereath-20, Carbomer, Aminomethyl Propanol, Trisodium EDTA, Ethylhexylglycerin, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Potassium Sorbate.

  • Other information

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

    Within US 1-800-510-4961

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Guthy-Renker®
    El Segundo, CA 90245

  • PRINCIPAL DISPLAY PANEL - 30g Jar Label

    RECLAIM®
    with Argireline®

    Revolutionary Anti-Aging Day® Cream SPF 15

    PRINCIPAL DISPLAY PANEL - 30g Jar Label
  • INGREDIENTS AND APPEARANCE
    RECLAIM REVOLUTIONARY ANTI-AGING DAY SPF15 
    octinoxate, octisalate, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70605-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    AHNFELTIOPSIS CONCINNA (UNII: SMF2K46G8D)  
    MUSKMELON (UNII: ZV095H5633)  
    BANANA (UNII: 4AJZ4765R9)  
    VITIS VINIFERA LEAF (UNII: R1H893D80E)  
    IRIS X GERMANICA NOTHOVAR. FLORENTINA ROOT (UNII: M30XO5X4XD)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70605-042-0715 g in 1 JAR; Type 0: Not a Combination Product12/30/201712/31/2021
    2NDC:70605-042-4330 g in 1 JAR; Type 0: Not a Combination Product12/30/2017
    3NDC:70605-042-1545 g in 1 JAR; Type 0: Not a Combination Product12/30/201712/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/30/2017
    Labeler - Guthy-Renker LLC (948861877)
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