BABY MINERAL SUNSCREEN ROLL-ON SPF-30 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [PROJECT SUNSCREEN]

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BABY MINERAL SUNSCREEN ROLL-ON SPF-30 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [PROJECT SUNSCREEN]
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NDC 72688-102-11
Set ID 5f029420-f81b-4603-b2bf-9cd4aaed3120
Category HUMAN OTC DRUG LABEL
Packager PROJECT SUNSCREEN
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENTS

    ZINC OXIDE 7%

    TITANIUM DIOXIDE 5%

  • PURPOSE

    SUNSCREEN

  • USES

    • HELPS PREVENT SUNBURN
    • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.
  • WARNINGS

    • FOR EXTERNAL USE ONLY
    • DO NOT USE ON DAMAGED OR BROKEN SKIN
    • WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE
    • STOP USE AND ASK A DOCTOR IF RASH OCCURS
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF PRODUCTS IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • SHAKE WELL BEFORE USE
    • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE
    • REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING
    • IMMEDIATELY AFTER TOWEL DRYING
    • AT LEAST EVERY 2 HOURS
    • SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
    • LIMIT TIME IN THE SUN, ESPECIALLY 10AM-2PM
    • WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES
    • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR
  • OTHER INFORMATION

    • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN
  • INACTIVE INGREDIENTS

    WATER, CAPRYLIC CAPRIC TRIGLYCERIDES, C12-15 ALKYL BENZOATE, DICAPRYLYL ETHER, PROPANEDIOL, GLYCERIN, ISOSTEARIC ACID, POLYHYDROXYSTEARIC ACID, PHENOXYETHANOL, BENZOIC ACID, ETHYLHEXYLGLYCERIN, GLYCERETH-2 COCOATE, CETYL PEG/PPG-10/1 DIMETHICONE, OCTYLDODECYL STEARYL CITRATE CROSSPOLYMER, SODIUM CHLORIDE, SODIUM HYALURONATE, TRIETHOXYCAPRYLYLSILANE

  • QUESTIONS?

    CALL 424.262.9462 OR VISIT PROJECTSUNSCREEN.COM

  • PRINCIPAL DISPLAY PANEL

    36740A_Baby Mineral - Handprint_Proof

  • INGREDIENTS AND APPEARANCE
    BABY MINERAL SUNSCREEN ROLL-ON  SPF-30
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72688-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION7 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    OCTYLDODECYL STEARATE (UNII: K6F16QGO28)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72688-102-1185 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product02/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/08/2019
    Labeler - PROJECT SUNSCREEN (080823314)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEGE-KURL, INC.021072509manufacture(72688-102)
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