Label: ANNA LOTAN PREMIUM BB CREAM SPF46 PALE BEIGE- titanium dioxide, octinoxate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 14, 2023

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

  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 16%
    Octinoxate 6.99%

  • Purpose:

    Sunscreen

  • Uses

    • Helps to prevent sunburn
    • If used as directed with other sun protective 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. If contact occurs rinse thoroughly 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

    • Apply liberally 15 minutes before sun exposure.
    • Reapply: • after 40 minutes of swimming or sweating. • immediately after towel drying • at least every 2 hours.
    Sun 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 of 15 or higher and other protection measures including: • Limit time in sun from 10 a.m.- 2 p.m. • Wear long-sleeve shirts, pants, hats and sunglasses.
    • Children under 6 months: Ask a doctor.

  • Inactive Ingredients

    Water, Caprylic/Capric Triglyceride, Dicaprylyl Ether, Cyclopentasiloxane, Talc, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Cyclohexasiloxane, Cetearyl Ethylhexanoate, Methyl Methacrylate Crosspolymer, Dipalmitoyl Hydroxyproline, Myristyl Myristate, Phenoxyethanol, Stearalkonium Hectorite, Microcrystalline Wax, Sodium Chloride, Paraffin, Polysilicone-11, Propylene Carbonate, Ethylhexylglycerin, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, BHT, Iron Oxides (CI 77491, CI 77492, CI 77499).

  • Questions or comments

    info@annalotanusa.com
    Tel: (781) 281 0954

  • SPL UNCLASSIFIED SECTION

    PRO

    SUN Select

    Pale Beige 1

    for normal/dry skin

    A multi-functional formula that serves as an optimal day care for normal to dry skin types, giving long lasting coverage, moisturisation and a wrinkle-relaxing effect.
    • A concentrated formula. A little will go a long way.
    • Applied in the morning, still looks great at the end of a busy day.
    • Formulated as a W/O emulsion that naturally repels water. However, care should be taken when regularly used on skin with enlarged pores!
    • Excellent spreading and adherence on the skin, offering optimal coverage for discolorations, including under eye dark circles!
    • A targeted combination of the amino acid proline and palm oil enhances skin penetration and provides a “plumping” anti-wrinkle effect, making it ideal for dry, mature skin.
    • Enriched with emollient oils that smooth the skin and prevent the typical accentuation of fine lines common with many concealing makeup products.
    • Vitamin E acts as antioxidant minimizing free radical damage.
    • Premium BB Cream combines concealing opacity with a light translucent veil which becomes apparent once the cream is fully absorbed. This veil allows your natural skin tone to shine through.

    Directions: Using sparingly, carefully spread the cream with fingertip massage to form an even layer on face, under eye area or wherever required until a smooth, even coverage is obtained.

    US Distribution: Anna Lotan USA Inc.
    16 Wheeling Ave, Woburn, MA 01801
    www.annalotanusa.com

  • Packaging

    PaleBeige-041

  • INGREDIENTS AND APPEARANCE
    ANNA LOTAN PREMIUM BB CREAM SPF46 PALE BEIGE 
    titanium dioxide, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76446-041
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE16 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.99 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TALC (UNII: 7SEV7J4R1U)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76446-041-301 in 1 CARTON09/15/2023
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02009/15/2023
    Labeler - Anna Lotan Ltd (600458368)