Label: PROTECT AND SERVE TINTED SUN SHIELD SPF 30- titanium dioxide and 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 January 6, 2014

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    TITANIUM DIOXIDE 10.9%

    ZINCE 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.

  • 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.

  • INSTRUCTIONS FOR USE

    DIRECTIONS

    USE AM. APPLY AS NEEDED TO FACE AND NECK AREA. CAN ALSO BE APPLIED TO THE EARS, HANDS AND DECOLLETAGE. 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: 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

    Protect-Serve_SPF-30_ART_Drug-Facts-Box2

    Protect-Serve_SPF-30_ART_Tube

  • INGREDIENTS AND APPEARANCE
    PROTECT AND SERVE  TINTED SUN SHIELD SPF 30
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49520-301-3260 mL in 1 TUBE
    2NDC:49520-301-355 mL in 1 BOTTLE
    3NDC:49520-301-422 mL in 1 PACKET
    4NDC:49520-301-315 mL in 1 TUBE
    5NDC:49520-301-3310 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/23/2012
    Labeler - mybody (004460532)
    Registrant - mybody (004460532)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!