Label: ALBA TERRATINT BLOOM SPF 15 LIP BALM- zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/13

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

  • Active Ingredient

    Zinc Oxide 5.5%

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  • Uses

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

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  • 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 doctor if skin rash occurs.  Keep out of reach of children.  If swallowed, get medical help or contact Poison Control Center right away. 

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  • Directions

    Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 months: ask a doctor. Skin Protection Measures: Spending time in sun increases risk of skin cancer and early skin aging. To decrease risk, use sunscreen with Broad Spectrum SPF 15 or higher, limit time in sun, especially 10am-2pm, and wear hats and sunglasses. 

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  • Inactive Ingredients

    Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Beeswax, Caprylic/Capric Triglyceride, Mica(Cl 77019), Titanium Dioxide(Cl 77891), Oryza Sativa (Rice) Bran Wax, Mentha Piperita (Peppermint) Oil*, Olea Europaea (Olive) Fruit Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Stevia Rebaudiana Leaf/Stem Extract*, Polyhydroxystearic Acid, Polyglyceryl-3 Diisostearate, Tocopheryl Acetate, Triethoxycaprylylsilane, Limonene*, Linalool*, Iron Oxides (CI 77491) *Certified Organic Ingredient

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  • Other Information

    Protect this product from excessive heat and direct sun

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  • Questions?

    Call (888) 659-7730 or visit www.albabotanica.com

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  • Principal Display Panel

    Image Components

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  • INGREDIENTS AND APPEARANCE
    ALBA TERRATINT BLOOM SPF 15 LIP BALM 
    zinc oxide stick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0303
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    RICE BRAN (UNII: R60QEP13IC)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ECHINACEA PURPUREA (UNII: QI7G114Y98)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    Product Characteristics
    Color pink Score     
    Shape Size
    Flavor PEPPERMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51514-0303-1 4.2 g in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 08/01/2012
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    Name Address ID/FEI Business Operations
    Autumn Harp, Inc. 064187883 manufacture(51514-0303)
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