Label: REVERSE IT KIT- titanium dioxide, zinc oxide kit

  • 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 June 30, 2014

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    TITANIUM DIOXIDE 10.9%

    ZINC OXIDE 4.01%

  • PURPOSE

    PURPOSE

    SUNSCREEN

  • INDICATIONS & USAGE

    USE HELPS PROTECT AGAINST SUNBURN

  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • WHEN USING

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER.
  • STOP USE

    • STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS.
  • 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.

  • DO NOT USE

    DO NOT USE

    • ON INFLAMED OR BROKEN SKIN.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    USE AM. APPLY AS NEEDED TO FACE AND NECK AREA. CAN ALSO BE APPLIED TO THE EARS, HANDS AND DECOLETAGE. APPLY EVENLY 15-30 MINUTES BEFORE SUN EXPOSURE AND AS NEEDED. REAPPLY AS NEEDED OR AFTER SWIMMING OR PERSPIRING. FOR BEST RESULTS

    • CLEANSE SKIN THOROUGHLY BEFORE APPLYING.
    • APPLY LIBERALLY TO FACE AND NECK BEFORE SUN EXPOSURE.
    • USE ALONE OR UNDER MAKE-UP.
    • CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR.
  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

    • STORE AT ROOM TEMPERATURE
    • AVOID HIGH TEMPERATURES AND PROTECT FROM FREEZING.
    • DO NOT USE IF INNER SEAL IS BROKEN.

    SUN ALERT

    LIMITING SUN EXPOSURE, WEARING PRODUCTIVE CLOTHING, AND USING SUNSCREEN MAY REDUCE THE RISKS OF SKIN AGING, SKIN CANCER AND OTHER HARMFUL EFFECTS OF THE SUN.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: CYCLOPENTASILOXANE, CYCLOMETHICONE, DIMETHICONE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER, SORBITAN ISOSTEARATE, TRIBEHENIN, CALCIUM BEHENATE, MELANIN, DIMETHICONOL, ALUMINA, PEG-10 DIMETHICONE, METHICONE, IRON OXIDES, CHOLECALCIFEROL, LYCOPENE, GLYCERIN, SUCROSE PALMITATE, LECITHIN.

  • QUESTIONS

    QUESTIONS OR COMMENTS?

    CALL 877.423.1314 * WWW.LOVEMYBODY.COM

  • PRINCIPAL DISPLAY PANEL

    REVERSE IT_TEMP_Front

    REVERSE IT_TEMP_Back-1

    REVERSE IT_TEMP_Page_2

  • INGREDIENTS AND APPEARANCE
    REVERSE IT KIT 
    titanium dioxide, zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49520-503
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49520-503-641 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1 1 
    Part 2 1 
    Part 3 1 
    Part 4 1 
    Part 1 of 4
    PROTECT AND SERVE  TINTED SUN SHIELD SPF 30
    titanium dioxide and zinc oxide lotion
    Product Information
    Item Code (Source)NDC:49520-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE11 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CALCIUM BEHENATE (UNII: J5VFA9V6YG)  
    MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    LYCOPENE (UNII: SB0N2N0WV6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCROSE PALMITATE (UNII: 3OSQ643ZK5)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/23/2012
    Part 2 of 4
    CLEAN ROUTINE 
    lotions, oils, powders, and creams
    Product Information
    Item Code (Source)NHRIC:49520-902
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    INGRCOCO-BETAINE (UNII: 03DH2IZ3FY)  
    INGRMYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)  
    INGRCURDLAN (UNII: 6930DL209R)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRLIME JUICE (UNII: 6416LES0Y6)  
    INGRCOCONUT ACID (UNII: 40U37V505D)  
    INGRSAFFLOWER ACID (UNII: Y788KS82OV)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRGLYCERYL LAURATE (UNII: Y98611C087)  
    INGRLAURIC ACID (UNII: 1160N9NU9U)  
    INGRGUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    INGRSUCROSE COCOATE (UNII: 3H18P0UK73)  
    INGRPOTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic09/24/2012
    Part 3 of 4
    A-TEAM 
    lotions, oils, powders, and creams
    Product Information
    Item Code (Source)NHRIC:49520-905
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRGLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    INGRC12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    INGRSAFFLOWER OIL (UNII: 65UEH262IS)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRSUCROSE LAURATE (UNII: 05Q7CD0E49)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGRGLYCERYL RICINOLEATE (UNII: ZUE0CEL42O)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGRMYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)  
    INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    INGRCAFFEINE (UNII: 3G6A5W338E)  
    INGRUNDECYLENOYL GLYCINE (UNII: 4D20464K2J)  
    INGRPEA (UNII: W4X7H8GYFM)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRSAFFLOWER ACID (UNII: Y788KS82OV)  
    INGRCOCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    INGRLECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    INGRACETYL CARBOXYMETHYL COCOYL GLYCINE (UNII: 3TNX4P92J3)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRCETEARETH-22 (UNII: 28VZG1E234)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRPOLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
    INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    INGRDIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)  
    INGRSTEARETH-21 (UNII: 53J3F32P58)  
    INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
    INGRCETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    INGRTROMETHAMINE (UNII: 023C2WHX2V)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/30/2014
    Part 4 of 4
    FUTURE IS BRIGHT 
    lotions, oils, powders, and creams
    Product Information
    Item Code (Source)NHRIC:49520-906
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRLAURYL LACTATE (UNII: G5SU0BFK7O)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
    INGRPENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATE (UNII: 832C4KF14X)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    INGRMYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)  
    INGRUNDECYLENOYL GLYCINE (UNII: 4D20464K2J)  
    INGRDIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGRCURDLAN (UNII: 6930DL209R)  
    INGRARGININE (UNII: 94ZLA3W45F)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    INGRMATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S)  
    INGRBORAGE OIL (UNII: F8XAG1755S)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRBEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRMETHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/30/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/10/2014
    Labeler - mybody (004460532)
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