Label: BALI BODY BB CREAM SPF 15 TAN- octocrylene, octinoxate, avobenzone, oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 25, 2022

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  • Product Information / Drug Facts

  • Directions:

    Apply to clean skin with fingertrips. Layer for additional coverage.

  • Warnings:

    For external use only. Keep out of direct sunlight or other sources of strong light. Product to be stored between 5-28°C. Discontinue use if irritation occurs. Subtle variations in appearance and texture of this product in no way affect its integrity.

    Keep out of reach of children.

    Please refer to balibodyco.com for further sun-safety instructions.

  • Use:

    Helps prevent sunburn, If used with other sun protection measures decreases the risk of skin cancer.

  • Active ingredients:

    Octocrylene 6.0%

    Octinoxate 5.0%

    Oxybenzone 3.0%

    Avobenzone 3.0%

    Purpose:

    Sunscreen

  • Inactive ingredients:

    Water (Aqua), Propylene Glycol, Cyclopentasiloxane, Ethylhexyl Stearate, Glyceryl Stearate, Cetearyl Alcohol, Tapioca Starch, Vitis Vinifera (Grape) Seed Oil, Cyclohexasiloxane, Potassium Cetyl Phosphate, Glycerin, CI 77891, Cl 77492, Cetearyl Olivate, Sorbitan Olivate, Phenoxyethanol, Mica, Benzyl Alcohol, Ethylhexylglycerin, Phytic Acid, Sodium Hydroxide, Butylene Glycol, Hydrolyzed Collagen, Sodium Hyaluronate, Acanthopanax Senticosus Root Extract, Camellia Sinensis Leaf Extract, Alcohol, Fragrance (Parfum), Potassium Sorbate, Cl 77491, Cl 77499.

  • Package Labeling:

    bb cream tan rev

  • INGREDIENTS AND APPEARANCE
    BALI BODY BB CREAM SPF 15 TAN 
    octocrylene, octinoxate, avobenzone, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ELEUTHERO (UNII: ZQH6VH092Z)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70630-0030-11 in 1 BOX03/25/2022
    135 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/25/2022
    Labeler - Bali Body Pty Ltd (757840223)
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