Label: LUNCHBOXWAX MINERAL BROAD SPECTRUM SUNSCREEN FACE CREAM SPF30- zinc oxide,titanium dioxide cream
LUNCHBOXWAX BODY SPF 30- zinc oxide,titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 9, 2019

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

  • LunchboxWax mineral broad spectrum sunscreen face cream SPF30+

    Lunchbox

    Micronized Zinc Oxide 10%..............Sunscreen

    Micronized Titanium Dioxide 6%..............Sunscreen

    Micronized Zinc 10%

    Micronized Titanium Dioxide 6%

    The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years reduces the chance of these harmful effects.

    Helps prevent sunburn

    If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by sun

    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 consult a doctor if rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Apply liberally 15 minutes before sun exposure

    Reapply

    After 40 minutes of swimming or sweating

    immediately after towel drying

    at least every 2 hours

    Children under 6 months of age: ask a doctor

    Aqua, Aloe barbadensis Leaf Juice, Grape Seed Oil, Glycerine, Jojoba Oil,

    Caprylic/Capric Triglyceride, Cetearyl Olivate, Sorbitan Olivate, Salicylic Acid, Sorbic Acid,

    Cetearyl Alcohol, Citric Acid, Calendula officinalis Seed Oil, Glyceryl Isostearate,

    Polyhydroxystearic Acid, Evening Primrose Oil, Mica, Mauritia flexuosa Fruit Oil, Aluminum Hydroxide,

    Lauric Acid, Tapioca, Iron Oxide Yellow, Potassium Sorbate, Aminoprypyl Ascorbyl Phosphate,

    Disodium Lauriminodipropionate Tocopheryl Phosphates, Xanthan Gum, Sodium Benzoate

  • Lunchboxwax Body SPF 30

    Lunchboxwax Body spf 30

    The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years reduces the chance of these harmful effects. Users: Helps pprevent sunburn if used as directed with other sun protection measures. Decreases the risk of skin cancer and early skin aging cause by the sun.

    Active Ingredients..........................................................Purpose

    Micronized Zinc Oxide 11%..............................................Sunscreen

    Micronized Titanium Dioxide 8%.......................................Sunscreen

    The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years reduces the chance of these harmful effects. Users: Helps pprevent sunburn if used as directed with other sun protection measures. Decreases the risk of skin cancer and early skin aging cause by the sun.

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

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

    Direction: apply liberally 15 minutes before sun exposure. reapply after 40 minutes of swimming or sweating immediately after towel drying. at least every 2 hours. Children under 6 months of age ask a doctor

    Inactive ingredients: Water/Aqua, Coco-Caprylate,
    Dicaprylyl Carbonate, Lauryl Glucoside, Polyglyceryl-2
    Dipolyhydroxystearate, Microcrystalline Cellulose,
    Cellulose Gum, Green Tea Extract, DL-Panthenol,
    Sodium Ascorbyl Phosphate, D-Alpha Tocopheryl
    Acetate, Phytic Acid, Triethoxycaprylylsilane,
    Polyhydroxystearic Acid, Xanthan Gum, Benzyl Alcohol,
    Ethylhexylglycerin, D-Alpha Tocopherol.

  • INGREDIENTS AND APPEARANCE
    LUNCHBOXWAX MINERAL BROAD SPECTRUM SUNSCREEN FACE CREAM SPF30 
    zinc oxide,titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69711-371
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    AMYLOSE, TAPIOCA (UNII: FL6W3SJ5M7)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    MICA (UNII: V8A1AW0880)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    SORBIC ACID (UNII: X045WJ989B)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69711-371-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/24/2019
    LUNCHBOXWAX BODY SPF 30 
    zinc oxide,titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69711-370
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    AMYLOSE, TAPIOCA (UNII: FL6W3SJ5M7)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    MICA (UNII: V8A1AW0880)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    SORBIC ACID (UNII: X045WJ989B)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69711-370-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/10/2019
    Labeler - Derma Soleil (079767886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deserving Health International Corp.202617023manufacture(69711-371, 69711-370)