MYBODY PROTECT AND SERVE SPF-30 (ZINC OXIDE) LOTION [MYBODY]

MYBODY PROTECT AND SERVE SPF-30 (ZINC OXIDE) LOTION [MYBODY]
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NDC 49520-302-32, 49520-302-52
Set ID cef96bec-57c1-4d8a-ad04-0007c128bfb4
Category HUMAN OTC DRUG LABEL
Packager mybody
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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