ENVIO 30 DAY DAILY ESSENTIALS DUO- benzoyl peroxide and salicylic acid kit

ENVIO 30 Day Daily Essentials Duo by

Drug Labeling and Warnings

ENVIO 30 Day Daily Essentials Duo by is a Otc medication manufactured, distributed, or labeled by Smart Skin Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

B.P.O. Cleanser

Drug Facts
Active Ingredients

Benzoyl Peroxide 5%
Purpose

Acne Treatment Gel
Use

for the management of acne
Warnings
For external use only.
When using this product
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the eyes, lips, and mouth
- avoid contact with hair and dyed fabrics, which may be bleached by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Do not use if you
- have very sensitive skin
- are sensitive to benzoyl peroxide
Stop use and ask a doctor
- if irritation becomes severe
Keep out of reach of children
- If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply a small amount to dampened skin
- cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- if going outside, apply sunscreen after using this product
- if irritation or sensitivity develops, stop use of both products and ask a doctor. Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Glycerin, Acrylates Copolymer, Cocamidopropyl Betaine, Cetearyl Alcohol, Glycol Distearate, Cetyl Alcohol, Panthenol, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate, Allantoin, Ethylhexylglycerin, Phenoxyethanol, Sodium Hydroxide
Other Information

Protect this product from excessive heat and direct sun.
Questions or Comments

Toll Free within USA 833-93-ENVIO
SPL UNCLASSIFIED SECTION

Dist. By: Smart Skin Health, LLC, Naples, FL 34108
SPL UNCLASSIFIED SECTION

S.A. Serum

Drug Facts
Active Ingredients

Salicylic Acid 2%
Purpose

Acne Gel Treatment
Use

for the management of acne
Warnings
For external use only
When using this product
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the eyes, lips, and mouth
- avoid contact with hair and dyed fabrics, which may be bleached by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Do not use if you
- have very sensitive skin
- are sensitive to Salicylic Acid
Stop use and ask a doctor if irritation becomes severe

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply evenly to affected area and allow to dry completely
- Can be used twice daily or as directed by a doctor
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- if irritation or sensitivity develops, stop use of both products and ask a doctor. Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
Inactive Ingredients

Water, Hydroxypropyl Starch Phosphate, Glycerin, Decyl Glucoside, Hamamelis Virginiana (Witch Hazel) Bark Extract, Polyglyceryl-4 Laurate/Sebacate, Polyglyceryl-6 Caprylate/Caprate, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Allantoin, Panthenol, Xanthan Gum, Glyceryl Stearate, Glyceryl Stearate Citrate, Lavandula Hybrida (Lavender Grosso) Oil1, Salix Alba (Willow) Bark Extract, Camellia Sinensis (Green Tea) Leaf Extract1, Ethylhexylglycerin, Phenoxyethanol

1 Certified Organic Ingredients

Other Information

Protect this product from excessive heat and direct sun.

Questions?

Toll Free within USA 833-93-ENVIO

SPL UNCLASSIFIED SECTION

Dist. By: Smart Skin Health, LLC
Naples, FL 34108

PRINCIPAL DISPLAY PANEL - Kit Carton

envio

PRINCIPAL DISPLAY PANEL - 44 mL Tube Label

envio™
skin

B.P.O. 5% CLEANSER
Benzoyl Peroxide Acne Treatment

1.5 fl. oz. /44 mL

Principal Display Panel - 44 mL Tube Label

PRINCIPAL DISPLAY PANEL - 14 g Tube Label

envio™
skin

S.A. 2% GEL SERUM
Salicylic Acid Acne Treatment

0.5 oz/14 g

Principal Display Panel - 14 g Tube Label

INGREDIENTS AND APPEARANCE

ENVIO 30 DAY DAILY ESSENTIALS DUO
benzoyl peroxide and salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81252-1000

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 81252-1000-1	1 in 1 CARTON	10/21/2021

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	44 mL
Part 2	1 TUBE	14 g
Part 3	1 TUBE	30 g

Part 1 of 3

B.P.O. CLEANSER
benzoyl peroxide gel

Product Information
Item Code (Source)	NDC: 81252-0101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
Glycerin (UNII: PDC6A3C0OX)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glycol Distearate (UNII: 13W7MDN21W)
Cetyl Alcohol (UNII: 936JST6JCN)
Panthenol (UNII: WV9CM0O67Z)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Allantoin (UNII: 344S277G0Z)
Ethylhexylglycerin (UNII: 147D247K3P)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Hydroxide (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 81252-0101-1	44 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	10/21/2021

Part 2 of 3

S.A. SERUM
salicylic acid gel

Product Information
Item Code (Source)	NDC: 81252-0201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Decyl Glucoside (UNII: Z17H97EA6Y)
Witch Hazel (UNII: 101I4J0U34)
Tea Tree Oil (UNII: VIF565UC2G)
Allantoin (UNII: 344S277G0Z)
Panthenol (UNII: WV9CM0O67Z)
Xanthan Gum (UNII: TTV12P4NEE)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Glyceryl Stearate Citrate (UNII: WH8T92A065)
Salix Alba Bark (UNII: 205MXS71H7)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Ethylhexylglycerin (UNII: 147D247K3P)
Phenoxyethanol (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 81252-0201-1	14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	10/21/2021

Part 3 of 3

CLARIFYING CLAY MASK
paste masks (mud packs) paste

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Bentonite (UNII: A3N5ZCN45C)
INGR	Kaolin (UNII: 24H4NWX5CO)
INGR	Glyceryl Ricinoleate (UNII: ZUE0CEL42O)
INGR	Medium-Chain Triglycerides (UNII: C9H2L21V7U)
INGR	Stearic Acid (UNII: 4ELV7Z65AP)
INGR	Alcohol (UNII: 3K9958V90M)
INGR	Cetyl Alcohol (UNII: 936JST6JCN)
INGR	Titanium Dioxide (UNII: 15FIX9V2JP)
INGR	Cranberry (UNII: 0MVO31Q3QS)
INGR	Salix Alba Bark (UNII: 205MXS71H7)
INGR	Passiflora Incarnata Flower (UNII: K8F3G29S6Z)
INGR	Chamomile (UNII: FGL3685T2X)
INGR	Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
INGR	Rosemary Oil (UNII: 8LGU7VM393)
INGR	Lonicera Japonica Flower (UNII: 4465L2WS4Y)
INGR	Lonicera Caprifolium Flower (UNII: 5N1WD9784U)
INGR	.Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N)
INGR	Allantoin (UNII: 344S277G0Z)
INGR	Glycol Distearate (UNII: 13W7MDN21W)
INGR	Glyceryl Monostearate (UNII: 230OU9XXE4)
INGR	Cocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	Xanthan Gum (UNII: TTV12P4NEE)
INGR	Fytic Acid (UNII: 7IGF0S7R8I)
INGR	Maltodextrin (UNII: 7CVR7L4A2D)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)
INGR	Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Potassium Sorbate (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
COSMETIC		10/21/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	10/21/2021

Labeler - Smart Skin Health, LLC (117039871)