Label: SUN PROTECT LIP BALM SPF 30- zinc oxide and titanium dioxide cream

  • NDC Code(s): 69555-036-04, 69555-036-05, 69555-036-06
  • Packager: Stream2Sea, LLC
  • 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 January 12, 2023

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  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredients

    Non Nano Zinc Oxide 6%, Non Nano Titanium Dioxide 7%

  • PURPOSE

    Purpose
    Sunscreen

  • INDICATIONS & USAGE

    Uses

    • 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

    Warnings

    • For external use only.
    • Do not use on damaged or broken skin.
    • Stop use and ask a doctor if rash occurs.
    • When using this product, keep out of eyes. Rinse with water to remove.
    • Keep out of reach of children, If swallowed, get medical help or contact a poison control centre right away.
  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
    • For children under 6 months of age; ask a doctor.
  • OTHER SAFETY INFORMATION

    Other information

    • This is a personal care item, and should be used by one individual only.
    • Protect this product from excessive heat and direct sun.
    • Do not use if safety seal is broken prior to purchase.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Sun Protected Lip Balm SPF 30 + - Naturally Naked

    Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea) Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa (Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil, Candelilla Cera Wax, Caprylic Capric Triglycerides, Copernicia Prunifers (Carnuba) Wax, Cetyl Esters, Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice Starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter.

    Sun Protected Lip Balm SPF 30 + - Cherry Vanilla

    Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea)Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa(Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil, Candelilla Cera Wax, Caprylic Capric Triglycerides, Copernicia Prunifera (Carnauba) Wax, Cetyl esters, Cherry Vanilla Flavor* Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice Starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter, Stevia Rebaudiana Leaf Extract.
    *Flavor is certified all natural.

    Sun Protected Lip Balm SPF 30 + - Cucumber Mint

    Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea)Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa (Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil , Candelilla Cera wax, Caprylic Capric Triglycerides, Copernicia Prunifera (Carnauba) Wax, Cetyl Esters, Cucumber Mint Flavor* Glyceryl Caprylate, Helianthus Annuus(Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter, Stevia Rebaudiana Leaf Extract.
    *Flavor is certified all natural.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    SUN PROTECT LIP BALM NATURALLY NAKED SPF 30 + 0.15 OZ - Label - NDC - 69555-036-01

    SUN PROTECT LIP BALM NATURALLY NAKED - Label

    SUN PROTECT LIP BALM CUCUMBER MINT SPF 30 + 0.15 OZ - Label - NDC - 69555-036-02

    SUN PROTECT LIP BALM CUCUMBER MINT - Label

    SUN PROTECT LIP BALM CHERRY VANILLA SPF 30 + 0.15 OZ - Label - NDC - 69555-036-03

    SUN PROTECT LIP BALM CHERRY VANILLA - Label
  • INGREDIENTS AND APPEARANCE
    SUN PROTECT LIP BALM SPF 30 
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69555-036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE280 mg  in 4 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE240 mg  in 4 g
    Inactive Ingredients
    Ingredient NameStrength
    ALARIA ESCULENTA (UNII: EJ9JK8J58D)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    STARCH, RICE (UNII: 4DGK8B7I3S)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    HOLY BASIL LEAF (UNII: SCJ765569P)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Cucumber Mint) , CHERRY (Cherry Vanilla) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69555-036-044 g in 1 TUBE; Type 0: Not a Combination Product07/10/2021
    2NDC:69555-036-054 g in 1 TUBE; Type 0: Not a Combination Product07/10/2021
    3NDC:69555-036-064 g in 1 TUBE; Type 0: Not a Combination Product07/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/10/2021
    Labeler - Stream2Sea, LLC (052920828)
    Registrant - Stream2Sea, LLC (052920828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stream2Sea, LLC052920828manufacture(69555-036)
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