LUNCHBOXWAX MINERAL BROAD SPECTRUM SUNSCREEN FACE CREAM SPF30- zinc oxide,titanium dioxide cream 
LUNCHBOXWAX BODY SPF 30- zinc oxide,titanium dioxide cream 
Derma Soleil
Reference Label Set Id: 8c175caf-cd5f-071f-e053-2995a90aac48

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.

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Lunchboxwax

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.

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)

Revised: 9/2019
Document Id: 92252610-bf95-2ec2-e053-2a95a90a7d6d
Set id: 92252919-3ade-6b5e-e053-2995a90a71ab
Version: 12
Effective Time: 20190909
 
Derma Soleil