Label: MYBODY PROTECT AND SERVE SPF-30- zinc oxide lotion

  • 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 September 3, 2015

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    ZINCE OXIDE 13.5%

  • 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.

  • OTHER SAFETY INFORMATION

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

    STORE AT ROOM TEMPERATURE.

    AVOID HIGH TEMPERATURES AND PROTECT FROM FREEZING.

    DO NOT USE IF INNER SEAL IS BROKEN.

  • 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 décolletage. 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.

  • GENERAL PRECAUTIONS

    SUN ALERT

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

  • INACTIVE INGREDIENT

    Inactive Ingredients Water/Aqua/Eau, C12-15 Alkyl Benzoate, Carthamus Tinctorius (Safflower) Seed Oil, Polysorbate 60, Cetyl Alcohol,
    Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Cetearyl Alcohol, Coco-Glucoside, Caprylic/Capric Triglyceride,Leuconostoc/Radish Root Ferment Filtrate, Isostearic Acid, Polyhydroxystearic Acid, Caprylyl Glycol, Sclerotium Gum, Hamamelis Virginiana (Witch Hazel) Water, Alcohol, Xanthan Gum, Phytic Acid, Citric Acid.

  • QUESTIONS

    QUESTIONS OR COMMENTS?

    CALL 877.423.1314 * WWW.MYBODYSKINCARE.COM

  • PRINCIPAL DISPLAY PANEL

    ProtectServe-Sun Shield-No Tint-Spf 30-08-04-15_p1

  • INGREDIENTS AND APPEARANCE
    MYBODY PROTECT AND SERVE  SPF-30
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49520-302
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49520-302-521 in 1 BOX
    1NDC:49520-302-3260 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/03/2015
    Labeler - mybody (004460532)
    Registrant - mybody (004460532)
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