Label: BBW SPF 35 PINK DREAM LIP BALM stick
BBW SPF 35 BERRY LIP BALM stick
BBW SPF 35 NATURAL LIP BALM stick

  • NDC Code(s): 51514-0365-1, 51514-0366-1, 51514-0367-1
  • Packager: Autumn Harp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 22, 2024

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  • ACTIVE INGREDIENT

    Avobenzone 2.5%

    Homosalate 10%

    Octisalate 5%

  • PURPOSE

    Avobenzone - Sunscreen

    Homosalate - Sunscreen

    Octisalate - Sunscreen

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure. Reapply:

    • After 80 minutes of swimming or sweating
    • Immediately after towel drying
    • at least every 2 hours
  • WARNINGS

    For external use only

    Do not use on domaged or broken skin

    When using this product, keep out of eyes. Rinse with water to remove

    Sop use and ask a doctor if rash occurs

  • INSTRUCTIONS FOR USE

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

  • OTHER SAFETY INFORMATION

    Limit time in the sun, especially from 10am - 2pm

    Wear long sleeved shirts, pants, hats and sunglasses

    Children under 6 months of age: ask a doctor

  • INACTIVE INGREDIENT

    Natural Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

    Berry Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Red 33 Lake (CI 17200), Red 7 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

    Summer Crush Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Beeswax, Ricinus Communis (Castor) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Titanium Dioxide (CI 77891), Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Iron Oxide (CI 77492), Iron Oxides (CI 77491), Red 7 Lake (CI 15850), Tocopherol, Iron Oxides (CI77499), Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

  • QUESTIONS

    1-800-395-1001

  • INDICATIONS & USAGE

    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

  • KEEP OUT OF REACH OF CHILDREN

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

  • PRINCIPAL DISPLAY PANEL

    Summer dream drug facts boxBerry drug facts boxNatural drug facts box

  • INGREDIENTS AND APPEARANCE
    BBW SPF 35 PINK DREAM LIP BALM 
    bbw spf 35 pink dream lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0367
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICA (UNII: V8A1AW0880)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    ANISE OIL (UNII: 6Y89129C8H)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0367-14 g in 1 TUBE; Type 0: Not a Combination Product01/22/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/22/2024
    BBW SPF 35 BERRY LIP BALM 
    bbw spf 35 berry lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0366
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICA (UNII: V8A1AW0880)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    ANISE OIL (UNII: 6Y89129C8H)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0366-14 g in 1 TUBE; Type 0: Not a Combination Product01/22/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/22/2024
    BBW SPF 35 NATURAL LIP BALM 
    bbw spf 35 natural lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0365
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICA (UNII: V8A1AW0880)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    ANISE OIL (UNII: 6Y89129C8H)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0365-14 g in 1 TUBE; Type 0: Not a Combination Product01/22/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/22/2024
    Labeler - Autumn Harp (064187883)
    Registrant - Autumn Harp (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp064187883manufacture(51514-0365, 51514-0366, 51514-0367)
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