Label: BENEFIT HELLO HAPPY AIR FOUNDATION SHADE 3- octinoxate, titanium dioxide stick

  • 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 January 6, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    OCTINOXATE 4.00%

    TITANIUM DIOXIDE 2.36%

    Purpose

    SUNSCREEN

  • Use

    • Helps prevent sunburn. 
    • If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

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

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: ask a doctor. 
    • Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. till 2 p.m.
    • Wear long-sleeved shirts, pants, hats & sunglasses.
  • Other information

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

  • Inactive ingredients

    Hydrogenated Polyisobutene, Polyethylene, Synthetic Fluorphlogopite, Polymethyl Methacrylate, C12-15 Alkyl Ethylhexanoate, Butyrospermum Parkii (Shea) Butter, Cetyl Peg/ Ppg-10/1 Dimethicone, C20-40 Pareth-3, Caprylyl Glycol, Phenoxyethanol, Silica, Lauroyl Lysine, Bht, Tocopheryl Acetate, Fragrance (Parfum), Linalool, Ascorbyl Palmitate, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Lavandula Angustifolia (Lavender) Flower/ Leaf/Stem Extract, Tocopherol, Geraniol, Limonene, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Citric Acid. [+/-: Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)].

  • Package Labeling:

    Label4TubeShade3

  • INGREDIENTS AND APPEARANCE
    BENEFIT HELLO HAPPY AIR FOUNDATION   SHADE 3
    octinoxate, titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66472-071
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE23.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    C20-40 PARETH-3 (UNII: 68103A23TQ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GINKGO (UNII: 19FUJ2C58T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66472-071-018.5 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2020
    Labeler - Benefit Cosmetics, LLC (070826813)