Label: ATTITUDE OCEANLY PHYTO-SUN TINTED - SPF 15 - BROAD SPECTRUM SUNSCREEN- zinc oxide stick

  • NDC Code(s): 61649-068-01
  • Packager: Attitude DBA 9055-7588 Québec Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 10, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc oxide 10%.

  • Purpose

    Sunscreen

  • Use

    Helps prevent sunburn

  • Warnings

    For external use only.

    Do not useon damaged or broken skin.

    Stop use and ask doctor ifrash occurs.

    When using this productkeep out of eyes. Rinse with water to remove.

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children older than 6 months.

    • Apply generously 15 minutes prior to sun exposure.
    • Reapply every 2 hours or after swimming, towel drying, perspiring heavily, or washing .
  • Inactive ingredients

    Helianthus Annuus (sunflower) seed wax, jojoba esters, caprylic/capric triglycerides, isopropyl palmitate, olus oil, isostearyl isostearate, zea mays (corn) starch, ricinus communis (castor) seed oil, polyhydroxystearic acid, glycerin, octyldodecanol, behenyl behenate, butyrospermum parkii (shea) butter, capryloyl glycerin / sebacic acid copolymer, aqua / water / eau, octyldodecyl myristate, sucrose laurate, sucrose stearate, acacia decurrens flower wax, polyglycerin-3, euphorbia cerifera (candelilla) wax, glycogen, rosmarinus officinalis (rosemary) leaf extract, fucus vesiculosus (bladderwrack) extract, iron oxides, isopropyl titanium triisostearate.

  • Other Information

    Store at temperatures below 90 °F.

    • Avoid contact of the packaging with water.
  • PRINCIPAL DISPLAY PANEL - 30 g Tube Label

    ATTITUDE™

    OCEANLY
    PLASTIC FREE BEAUTY™

    PHYTO-SUN

    tinted cream
    SPF 15

    BROAD SPECTRUM SUNSCREEN

    NPN 80112334

    ZINC OXIDE
    BLADDERWRACK EXTRACT
    PHYTOGLYCOGEN

    STICK
    30 g | 1 oz.

    PRINCIPAL DISPLAY PANEL - 30 g Tube Label
  • INGREDIENTS AND APPEARANCE
    ATTITUDE OCEANLY PHYTO-SUN TINTED - SPF 15 - BROAD SPECTRUM SUNSCREEN 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61649-068
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CORN OIL (UNII: 8470G57WFM)  
    C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BEHENYL BEHENATE (UNII: K8NU647RJ0)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    WATER (UNII: 059QF0KO0R)  
    OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)  
    SUCROSE LAURATE (UNII: 05Q7CD0E49)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    GLYCOGEN (UNII: 309GSC92U1)  
    ROSEMARY (UNII: IJ67X351P9)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61649-068-0130 g in 1 TUBE; Type 0: Not a Combination Product01/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02001/25/2023
    Labeler - Attitude DBA 9055-7588 Québec Inc. (201137051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Attitude DBA 9055-7588 Québec Inc.204307099manufacture(61649-068) , label(61649-068) , pack(61649-068) , analysis(61649-068)
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