Label: BE SWEET SPF 15 TINTED ABLAZE- avobenzone, octinoxate gel

  • 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 February 16, 2018

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  • Drug Facts

  • Active ingredients

    Avobenzone - 3.0%
    Octinoxate - 7.5%

    Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • Warnings

    Skin Cancer/Skin Aging 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.

    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.

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

  • Directions for sunscreen use:

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months of age, ask a doctor prior to use
  • Other Information

    Protect the product in this container from excessive heat and direct sun. 

  • Questions or Comments

    www.beautybypopsugar.com

  • Inactive Ingredients:

    Ricinus Communis (Castor) Seed Oil, Lanolin Oil, Octyldodecanol, Propylene Glycol Ricinoleate, Euphorbia Cerifera (Candelilla) Wax, Isopropyl Lanolate, Lanolin, C12-15 Alkyl Benzoate, Oleyl Alcohol, Polybutene, Ozokerite, Paraffin, Copernicia Cerifera (Carnauba) Wax, Ethylhexyl  Palmitate, Propylene Glycol, Flavor (Aroma), Disteardimonium Hectorite, Ascorbyl Palmitate, Tribehenin, Vitis Vinifera (Grape) Seed Oil, Retinyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Tocopherol, Glycine Soja (Soybean) Oil, Sorbitan Isostearate, Stevioside, Aloe Barbadensis Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, BHT, Palmitoyl Tripeptide-1, Hibiscus Sabdariffa Flower Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Camellia Sinensis Leaf Extract. MAY CONTAIN (+/-): Titanium Dioxide (CI 77891), Mica (CI 77019), Iron Oxides (CI
    77491, 77499), Red 7 Lake (CI 15850), Yellow 5 Lake (CI 19140), Yellow 6 Lake (CI 15985), Red 22 Lake (CI 45380), Red 28 Lake (CI 45410).

  • Package Labeling:

    Outer PackageInner Package4Ablaze

  • INGREDIENTS AND APPEARANCE
    BE SWEET SPF 15 TINTED  ABLAZE
    avobenzone, octinoxate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72112-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    LANOLIN OIL (UNII: OVV5IIJ58F)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PROPYLENE GLYCOL RICINOLEATE (UNII: WD6G36K42U)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    LANOLIN (UNII: 7EV65EAW6H)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72112-004-011 in 1 CARTON03/01/2018
    12.7 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2018
    Labeler - Bona Fide Beauty Lab PS LLC (064526749)
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