Label: VITAMIN C BB BEAUTY BALM SHEER TINT SFP 30- zinc oxide lotion

  • 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 17, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide 20%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
  • 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 or irritation develops and lasts.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Daily, alone or under make-up.
    • Apply liberally 15 minutes before sun exposure and as needed.
    • Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking.
    • Use water resistant sunscreen if swimming or sweating.
    • 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 sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long sleeve shirts, pants and sunglasses.
    • Children under 6 months: ask a doctor.
  • Non Medicinal Ingredients

    Aloe Barbadensis Leaf Juice1, Purified Water (Aqua), Caprylic/Capric Triglycerides, Vegetable Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil1, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Polyglyceryl-2 Stearate, Helianthus Annuus (Sunflower) Seed Oil1, Punica Granatum (Pomegranate) Seed Oil1, Hydrogenated Castor Oil, Dimethicone, Magnesium Sulfate, Sorbitan Sesquioleate, Fruit Stem Cells (Malus Domestica, Solar Vitis) and BioActive Berry Complex1, Sodium Hyaluronate, Magnesium Ascorbyl Phosphate (Vitamin C), Borago Officinalis (Borage) Seed Oil1, Cucumis Sativus (Cucumber) Fruit Extract1, Zea Mays (Corn) Starch1, Camellia Sinensis (White Tea) Leaf Extract12, Hibiscus Sabdariffa Flower Extract12, Tocopherol, Iron Oxides, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Tangerina (Tangerine) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil1


    1
    Certified Organic/Organic
    2
    Fair Trade/Biologique
  • Other Information

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

    Call (888) 898-6955 or visit www.Andalou.com

  • SPL UNCLASSIFIED SECTION

    Dist. by Andalou Naturals
    Novato, CA 94945 USA

  • PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton

    NEW LOOK

    ANDALOU
    NATURALS

    NON
    GMO

    BB

    Vitamin C
    BEAUTY BALM

    Sheer Tint
    SPF 30

    with Vitamin C
    Complexion Defense

    Broad Spectrum Protection

    FRUIT
    STEM
    CELL

    SCIENCE®

    BRIGHTENING

    NPN 80042776

    2 fl oz e 58 mL

    PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    VITAMIN C BB BEAUTY BALM SHEER TINT SFP 30 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55560-0108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    APPLE (UNII: B423VGH5S9)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    ACAI (UNII: 46AM2VJ0AW)  
    ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU)  
    EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    CUCUMBER (UNII: YY7C30VXJT)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    WHITE TEA (UNII: O0M3396E09)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MANDARIN OIL (UNII: NJO720F72R)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55560-0108-11 in 1 CARTON12/10/2012
    158 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/10/2012
    Labeler - Andalou naturals (011472720)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Deep Inc189788201MANUFACTURE(55560-0108)