DERMA SOLEIL MINERAL BROAD SPECTRUM SPF 30 SUNSCREEN- titanium dioxide,zinc oxide lotion DERMA SOLEIL MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN- zinc oxide,titanium dioxide lotion DERMA SOLEIL MINERAL AGE-FREE FACIAL BROAD SPECTRUM SPF 50 SUNSCREEN- zinc oxide,titanium dioxide cream DERMA SOLEIL TINTED MINERAL AGE-FREE FACIAL BB BROAD SPECTRUM SPF 30 SUNSCREEN- zinc oxide,titanium dioxide cream

Derma Soleil Mineral Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Derma Soleil Mineral Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Derma Soleil, Deserving Health International Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Derma Soleil Mineral Broad Spectrum Sunscreen Lotion SPF 50

Sunscreen

Micronized Zinc Oxide 16%

Micronized Titanium Dioxide 8%

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

Water, Coco-Caprylate, Dicaprylyl Carbonate, Lauryl Glucoside,

Polyglyceryl-2 Dipolyhydroxystearate, Glycerin, 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

Derma Soleil Tinted Mineral Age-Free Facial BB Broad Spectrum Sunscreen SPF 30

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

Derma Soleil Mineral Agre-Free Ficial Broad Spectrum Sunscreen SPF 50

Sunscreen

Micronized Zinc Oxide 16%

Micronized Titanium Dioxide 9%

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

Derma Soleil Mineral Broad Spectrum Sunscreen Lotion SPF 30

Sunscreen

Micronized Zinc Oxide 11%

Micronized Titanium Dioxide 8%

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

Water, Coco-Caprylate, Dicaprylyl Carbonate, Lauryl Glucoside,

Polyglyceryl-2 Dipolyhydroxystearate, Glycerin, 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

DERMA SOLEIL MINERAL BROAD SPECTRUM SPF 30 SUNSCREEN 
titanium dioxide,zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69711-340
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
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERIN (UNII: PDC6A3C0OX)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)
FYTIC ACID (UNII: 7IGF0S7R8I)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69711-340-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/11/2019

DERMA SOLEIL MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN 
zinc oxide,titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69711-540
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	16 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERIN (UNII: PDC6A3C0OX)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)
FYTIC ACID (UNII: 7IGF0S7R8I)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
BENZYL ALCOHOL (UNII: LKG8494WBH)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69711-540-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/11/2019

DERMA SOLEIL MINERAL AGE-FREE FACIAL BROAD SPECTRUM SPF 50 SUNSCREEN 
zinc oxide,titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69711-541
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	16 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 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: 69711-541-01	100 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	06/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/10/2019

DERMA SOLEIL TINTED MINERAL AGE-FREE FACIAL BB BROAD SPECTRUM SPF 30 SUNSCREEN 
zinc oxide,titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69711-341
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: 69711-341-01	100 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	06/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/11/2019

Labeler - Derma Soleil (079767886)

Establishment
Name	Address	ID/FEI	Business Operations
Deserving Health International Corp.		202617023	manufacture(69711-340, 69711-341, 69711-540, 69711-541)