BABY MINERAL SUNSCREEN ROLL-ON SPF-50 (ZINC OXIDE) LOTION [PROJECT SUNSCREEN]

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BABY MINERAL SUNSCREEN ROLL-ON SPF-50 (ZINC OXIDE) LOTION [PROJECT SUNSCREEN]
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NDC 72688-103-11
Set ID ce0e63ef-67dd-4c9b-b46b-1f791f9c1ec4
Category HUMAN OTC DRUG LABEL
Packager PROJECT SUNSCREEN
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    ZINC OXIDE 18%

  • 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 (Aqua), Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Glycerin, Coconut Alkanes, Coco-Caprylate/Caprate, Bis-Stearyl Dimethicone, Cetearyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Isostearate, Galactoarabinan, Niacinamide, Capryloyl Glycerin/Sebacic Acid Copolymer, Polyhydroxystearic Acid, Tocopheryl Acetate, Physalis Angulata Extract, Caprylic/Capric Triglycerides, 1,2-Hexanediol, Propanediol, Caprylhydroxamic Acid

  • QUESTIONS?

    CALL 424.262.9462 OR VISIT PROJECTSUNSCREEN.COM

  • PRINCIPAL DISPLAY PANEL

    PS-Baby-Bottle-Label-3oz-SPF_50-Handprints

    Baby_SPF-50_Drug Facts Box

  • INGREDIENTS AND APPEARANCE
    BABY MINERAL SUNSCREEN ROLL-ON  SPF-50
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72688-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
    CETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72688-103-1185 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product03/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/04/2019
    Labeler - PROJECT SUNSCREEN (080823314)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEGE-KURL, INC.021072509manufacture(72688-103)
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