Label: CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING SPF-30 SUNSCREEN- octinoxate, octisalate, zinc oxide cream

  • NDC Code(s): 70764-205-22, 70764-205-52
  • Packager: CONTROL CORRECTIVE SKINCARE INC
  • 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 September 22, 2023

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  • ACTIVE INGREDIENTS

    OCTINOXATE (6.9%)

    OCTISALATE (3.0%)

    ZINC OXIDE (4.0%)

  • PURPOSE

    SUNSCREEN

  • USE

    A MULTI-PURPOSE , NON-GREASY MOISTURIZER AND SUNSCREEN TO HELP REDUCE FREE RADICAL DAMAGE AND ENCOURAGE SKIN BRIGHTENING.

  • WARNING

    FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER. DISCONTINUE USE AND ASK A DOCTOR IF IRRITATION OR RASH DEVELOPS.

  • DIRECTIONS

    MAY BE USED TWICE DAILY WHEN APPLIED TO CLEAN, DRY SKIN.

  • OTHER SAFETY INFORMATION

    SUN ALERT: LIMITING SUN EXPOSURE, WEARING PROTECTIVE CLOTHING, AND USING SUNSCREEN MAY REDUCE THE RISK OF SKIN AGING, SKIN CANCER, AND OTHER HARMFUL EFFECTS OF THE SUN.

  • INACTIVE INGREDIENTS

    WATER, ALOE BARBADENSIS LEAF, GLYCERIN, PROPYLENE GLYCOL, ISOPROPYL PALMITATE, CAPRYLIC/CAPRIC TRIGLYCERIDES, CYCLOPENTASILOXANE, KOJIC DIPALMITATE, CETEARYL ALCOHOL, CETEARETH-20, VP/EICOSENE COPOLYMER, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, CYCLOTETRASILOXANE, ARCTOSTAPHYLOS UVA URSI LEAF EXTRACT, GLYCYRRHIZA GLABRA ROOT EXTRACT, PHENOXYETHANOL, BUTYROSPERMUM PARKII SHEA BUTTER, PERSEA GRATISSIMA OIL, FRAGRANCE, TOCOPHERYL ACETATE, DISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, ARBUTIN, CITRIC ACID, METHYLISOTHIAZOLINONE

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • QUESTIONS OR COMMENTS:

    WWW.CONTROLCORRECTIVE.COM

    TOLL FREE 1-866-290-4290  MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    Box IntensiveSkinBrightening CreamCarton-new2-olL

  • INGREDIENTS AND APPEARANCE
    CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING   SPF-30 SUNSCREEN
    octinoxate, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70764-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.9 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    KOJIC DIPALMITATE (UNII: 13N249RWTM)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    GLYCYRRHIZA INFLATA ROOT (UNII: 1MV1Z7MKVQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ARBUTIN (UNII: C5INA23HXF)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70764-205-521 in 1 BOX09/11/2018
    1NDC:70764-205-2274 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/11/2018
    Labeler - CONTROL CORRECTIVE SKINCARE INC (023999357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chemolee Lab Corporation809982754manufacture(70764-205)
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