RECLAIM REVOLUTIONARY ANTI-AGING DAY SPF15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) CREAM [GUTHY-RENKER LLC]

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  • RECLAIM REVOLUTIONARY ANTI-AGING DAY SPF15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) CREAM [GUTHY-RENKER LLC]

RECLAIM REVOLUTIONARY ANTI-AGING DAY SPF15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) CREAM [GUTHY-RENKER LLC]
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NDC 70605-042-07, 70605-042-15, 70605-042-43
Set ID 4b735c91-f650-4531-8744-c211d57a3e28
Category HUMAN OTC DRUG LABEL
Packager Guthy-Renker LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Fact Label

  • Active ingredient

    Octinoxate 7.5%
    Octisalate 5.0%
    Oxybenzone 3.0%

  • Purpose

    Sunscreen

  • Use

    • Helps prevent sunburn
  • Warnings

    • Skin Cancer/Skin 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.

    Stop use and ask a doctor if rash occurs

    • When using this product keep out of eyes. Rinse with water to remove.

    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.
  • Other information

    • Protect this product from excessive heat and direct sun.
  • Inactive ingredients

    water, Octyldodecyl neopentanoate, caprylic/capric triglyceride, cetyl alcohol, glyceryl stearate, PEG-100 stearate, cetearyl alcohol, Dipalmitoyl Hydroxyproline, PEG-8/SMDI copolymer, 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, triethanolamine, trisodium EDTA, ethylhexylglycerin, Caprylyl glycol, hexylene glycol, potassium sorbate, phenoxyethanol.

  • Questions or comments?

    Within the USA 1-800-510-4961

  • SPL UNCLASSIFIED SECTION

    Distributed by Guthy-Renker®
    Palm Desert, CA 92260 USA

  • PRINCIPAL DISPLAY PANEL - 7.5%/5.0%/3.0% Jar Label

    PRINCIPAL
    SECRET®

    RECLAIM®
    with Argireline®

    Revolutionary
    Anti-Aging Day® Cream
    SPF 15

    Active Ingredients:
    Octinoxate 7.5%
    Octisalate 5.0%
    Oxybenzone 3.0%

    Peel here

    PRINCIPAL DISPLAY PANEL - 7.5%/5.0%/3.0% 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 Product12/30/2017
    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 Product12/30/2017
    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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