Label: LUNCHBOXWAX MINERAL BROAD SPECTRUM SUNSCREEN FACE CREAM SPF30- zinc oxide,titanium dioxide cream
LUNCHBOXWAX BODY SPF 30- zinc oxide,titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69711-370-01, 69711-371-01 - Packager: Derma Soleil
- 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.
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- Official Label (Printer Friendly)
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LunchboxWax mineral broad spectrum sunscreen face cream SPF30+
Micronized Zinc Oxide 10%..............Sunscreen
Micronized Titanium Dioxide 6%..............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.
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
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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.
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.
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INGREDIENTS AND APPEARANCE
LUNCHBOXWAX MINERAL BROAD SPECTRUM SUNSCREEN FACE CREAM SPF30
zinc oxide,titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69711-371 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69711-371-01 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/24/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/24/2019 LUNCHBOXWAX BODY SPF 30
zinc oxide,titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69711-370 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 11 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 8 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69711-370-01 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/10/2019 Labeler - Derma Soleil (079767886) Establishment Name Address ID/FEI Business Operations Deserving Health International Corp. 202617023 manufacture(69711-371, 69711-370)