Label: CONTROL CORRECTIVE TINTED MOISTURIZER SPF-30 SUNSCREEN- titanium dioxide, zinc oxide cream

  • NDC Code(s): 70764-206-22, 70764-206-52
  • 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

    TITANIUM DIOXIDE (2.5%)

    ZINC OXIDE (6.0%)

  • PURPOSE

    SUNSCREEN

  • USE

    THIS HYDRATING MULTI-PURPOSE MOISTURIZER DELIVERS PROTECTION AND LIGHT UNIVERSAL COVERAGE FOR ALL SKIN TYPES. CONTAINS SUPER HUMECTANTS, SODIUM PCA, SODIUM HYALURONATE (AKA HYALURONIC ACID) AND PANTHENOL DL TO PROIDE NON-GREASY HYDRATION. ALOE VERA, ALLANTOIN AND VITAMIN C DELIVER THE BOTANICALS TO DEFEND AGAINST ENVIRONMENTAL STRESS AND IRRITATION. ALL NATURAL PHYSICAL SUNSCREEN AGENTS GENTLY REFLECT THE SUN'S RAYS. BOOSTS RADIANCE FOR A MORE EVEN, BALANCED COMPLEXION.

  • 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 OR WHENEVER EXPOSED TO THE SUN. APPLY GENEROUSLY TO FACE AND NECK.

  • 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, ETHYLHEXYL PALMITATE, PROPANEDIOL, C12-15 ALKYL BENZOATE, CYCLOPENTASILOXANE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POLYSODBATE 60, GLYCERYL STEARATE, PEG-100 STEARATE, GLYCERIN, SODIUM PCA, CETYL ALCOHOL, DIMETHICONE, SODIUM HYALURONATE, CHAMOMILLA RECUTITIA (MATRICARIA) FLOWER EXTRACT, CAMELLIA OLEIFERA LEAF EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, PANTHENOL DL, ALOE BARBADENSIS LEAF, CITRIC ACID, CAPRYLYL METHICONE, ALUMINA, POLYHYDROXYSTEARIC ACID, TRIETHOXYSILYETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, LAYRYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, SODIUM CITRATE, PHENOXYETHANOL, XANTHAN GUM, IRON OXIDES, CYCLOTETRASILOXANE, ALLANTOIN, TRIETHOCYCAPRYLYLSILANE, DISODIUM EDTA, FRAGRANCE, 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

    01b UC_Tinted Moisturizer with SPF 30

  • INGREDIENTS AND APPEARANCE
    CONTROL CORRECTIVE TINTED MOISTURIZER   SPF-30 SUNSCREEN
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70764-206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70764-206-521 in 1 BOX09/11/2018
    1NDC:70764-206-2274 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(70764-206)
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