BALI BODY BB CREAM SPF 15 (OCTINOXATE, OCTOCRYLENE, OCYBENZONE, AVOBENZONE CREAM) CREAM [BALI BODY PTY LTD]

BALI BODY BB CREAM SPF 15 (OCTINOXATE, OCTOCRYLENE, OCYBENZONE, AVOBENZONE CREAM) CREAM [BALI BODY PTY LTD]
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NDC 70630-1605-1, 70630-1605-2
Set ID 9c6efc8e-f554-4982-892a-1c064073f15e
Category HUMAN OTC DRUG LABEL
Packager Bali Body Pty Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • PRINCIPAL DISPLAY PANEL

    BB Box PDP TanBB Box PDP Natural

    Dark AWFair AW

    Octinoxate 4%

    Avobenzone 4%

    Oxybenzone 3%

    Octocrylene 2.7%

    Keep out of reach of children.

    A multi-tasking beauty cream.

    Provides SPF 15 protection.

    Shake well before use. Apply liberaly 15 minutes before sun exposure.

    Children under 6 months old: Ask a doctor.

    Re-apply every 2 hours.

    Use water-resistant sunscreen if swimming or sweating.

    Store in cool dry place.

    Skin Cancer/Skin Ageing Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.

    This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    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.

    Always wear a hat, protective clothing and sunglasses.

    Apply liberally 15 minutes before sun exposure.

  • INGREDIENTS AND APPEARANCE
    BALI BODY BB CREAM SPF 15 
    octinoxate, octocrylene, ocybenzone, avobenzone cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-1605
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 mg  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4 mg  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 mg  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70630-1605-135 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/201608/31/2021
    2NDC:70630-1605-235 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/201609/30/2022
    3NDC:70630-1605-33 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/08/2016
    Labeler - Bali Body Pty Ltd (757840223)
    Registrant - Bali Body Pty Ltd (757840223)

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