ROCCOS OLD SCHOOL SUNSCREEN SPF 30 (OCTINOXATE) CREAM [ROCCO'S OLD SCHOOL]

ROCCOS OLD SCHOOL SUNSCREEN SPF 30 (OCTINOXATE) CREAM [ROCCO'S OLD SCHOOL]
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NDC 24488-009-12
Set ID 9f00e6b8-134a-40d6-979c-a350c3ee93f7
Category HUMAN OTC DRUG LABEL
Packager Rocco's Old School
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredient

    Octinoxate 7.5% ..............................................Sunscreen agent
    Benzophenone-3 6%......................................Sunscreen agent
    Titanium Dioxide 1.5%....................................Sunscreen agent

  • Use

    • To help prevent sunburn from UVB radiation and
      protect against long-UVA rays linked to deep premature
      skin-aging.
  • Warnings

    For external use only.

  • When using this product

    • Keep out of eyes.
    • Rinse with water to remove.
  • Stop use and ask doctor if

    rash or irritation develops and lasts.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally on face, neck and other
      exposed areas every morning after cleansing or at least 15
      minutes before sun exposure, or as needed.
    • Reapply if excess perspiration or product wear occurs, and after
      swimming or towel drying.
      For children under six months
  • For children under six months of age

    • Consult a doctor.
    • Store at controlled room temperature 15° - 30° C
      (59° - 86°F).
  • Inactive ingredients

    Purified Water/Aqua/Eu, Allantoin,
    Glyceryl Stearate and PEG-100 Stearate, Stearic Acid,
    Squalene, Beeswax, Aloe Barbadensis Leaf Juice, Sodium
    Hyaluronate, Carbomer, Potassium sorbate,
    Sodium Benzoate

  • 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.

  • Questions?

    661-877-4280

  • PRINCIPAL DISPLAY PANEL

    Place Holder Text

    Roccos SPF Label

  • INGREDIENTS AND APPEARANCE
    ROCCOS OLD SCHOOL  SUNSCREEN SPF 30
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE13.275 mL  in 177 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE10.62 mL  in 177 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.655 mL  in 177 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SQUALENE (UNII: 7QWM220FJH)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-009-12177 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/16/2011
    Labeler - Rocco's Old School (961956229)
    Registrant - Creations Garden Natural Products Inc. (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creations Garden Natural Products Inc.961956229manufacture

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