ENVIO 30 DAY DAILY ESSENTIALS DUO- benzoyl peroxide and salicylic acid 
Smart Skin Health, LLC

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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ENVIO™ 30 Day Daily Essentials Duo

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

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

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

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

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

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

PRINCIPAL DISPLAY PANEL - Kit Carton

envio

Principal Display Panel - Kit Carton

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
ENVIO 30 DAY DAILY ESSENTIALS DUO 
benzoyl peroxide and salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81252-1000
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81252-1000-11 in 1 CARTON10/21/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 44 mL
Part 21 TUBE 14 g
Part 31 TUBE 30 g
Part 1 of 3
B.P.O. CLEANSER 
benzoyl peroxide gel
Product Information
Item Code (Source)NDC:81252-0101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81252-0101-144 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/21/2021
Part 2 of 3
S.A. SERUM 
salicylic acid gel
Product Information
Item Code (Source)NDC:81252-0201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81252-0201-114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/21/2021
Part 3 of 3
CLARIFYING CLAY MASK 
paste masks (mud packs) paste
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWater (UNII: 059QF0KO0R)  
INGRGlycerin (UNII: PDC6A3C0OX)  
INGRBentonite (UNII: A3N5ZCN45C)  
INGRKaolin (UNII: 24H4NWX5CO)  
INGRGlyceryl Ricinoleate (UNII: ZUE0CEL42O)  
INGRMedium-Chain Triglycerides (UNII: C9H2L21V7U)  
INGRStearic Acid (UNII: 4ELV7Z65AP)  
INGRAlcohol (UNII: 3K9958V90M)  
INGRCetyl Alcohol (UNII: 936JST6JCN)  
INGRTitanium Dioxide (UNII: 15FIX9V2JP)  
INGRCranberry (UNII: 0MVO31Q3QS)  
INGRSalix Alba Bark (UNII: 205MXS71H7)  
INGRPassiflora Incarnata Flower (UNII: K8F3G29S6Z)  
INGRChamomile (UNII: FGL3685T2X)  
INGRCalendula Officinalis Flower (UNII: P0M7O4Y7YD)  
INGRRosemary Oil (UNII: 8LGU7VM393)  
INGRLonicera Japonica Flower (UNII: 4465L2WS4Y)  
INGRLonicera Caprifolium Flower (UNII: 5N1WD9784U)  
INGR.Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N)  
INGRAllantoin (UNII: 344S277G0Z)  
INGRGlycol Distearate (UNII: 13W7MDN21W)  
INGRGlyceryl Monostearate (UNII: 230OU9XXE4)  
INGRCocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)  
INGRDimethicone (UNII: 92RU3N3Y1O)  
INGRCaprylyl Glycol (UNII: 00YIU5438U)  
INGRXanthan Gum (UNII: TTV12P4NEE)  
INGRFytic Acid (UNII: 7IGF0S7R8I)  
INGRMaltodextrin (UNII: 7CVR7L4A2D)  
INGRCitric Acid Monohydrate (UNII: 2968PHW8QP)  
INGRTrisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
INGRCarbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
INGRSodium Hydroxide (UNII: 55X04QC32I)  
INGRPotassium Sorbate (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC10/21/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/21/2021
Labeler - Smart Skin Health, LLC (117039871)

Revised: 1/2023
Document Id: 04750ce1-a27c-43df-a7bf-ece68646251e
Set id: 76e1674f-eab8-4798-8b80-2974a5f5c086
Version: 3
Effective Time: 20230106
 
Smart Skin Health, LLC