FDA.reportPublic FDA data

ENVIO 30 Day Daily Essentials Duo

Manufacturer
Smart Skin Health, LLC
Effective date
2023-01-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:53:08

Label at a glance#

ProductENVIO 30 Day Daily Essentials Duo
Active ingredientBenzoyl Peroxide, Salicylic Acid
Label structure23 sections

Dosage and administration

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, ap...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

B.P.O. Cleanser

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment Gel

Use

INDICATIONS & USAGE SECTION

for the management of acne

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - DO NOT USE SECTION

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if irritation becomes severe

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Questions or Comments

OTC - QUESTIONS SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Gel Treatment

Use

INDICATIONS & USAGE SECTION

for the management of acne

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - DO NOT USE SECTION

  • have very sensitive skin
  • are sensitive to Salicylic Acid

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation becomes severe

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

Toll Free within USA 833-93-ENVIO

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

envio

Principal Display Panel - Kit Carton
Principal Display Panel - Kit Carton

PRINCIPAL DISPLAY PANEL - 44 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - 44 mL Tube Label

PRINCIPAL DISPLAY PANEL - 14 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

envio™
skin

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

0.5 oz/14 g

Principal Display Panel - 14 g Tube Label
Principal Display Panel - 14 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308696benzoyl peroxide 5 % Medicated Liquid SoapPSN3
346298salicylic acid 2 % Topical GelPSN3
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCD3
346298salicylic acid 0.02 MG/MG Topical GelSCD3
308696benzoyl peroxide 5 % Medicated Liquid SoapSY3
346298salicylic acid 2 % Topical GelSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81252-1000-12024-07-30C16284748780-11030e365-2add-111a-e063-dadaa90a10e2ENVIO™ 30 Day Daily Essentials Duo
81252-1000-12024-01-30C16284748780-11030e365-2add-111a-e063-dadaa90a10e2ENVIO™ 30 Day Daily Essentials Duo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81252-0101-1ENVIO 30 Day Daily Essentials Duo44 mL in 1 TUBEGEL44 mL5 g in 100mL3
81252-0201-1ENVIO 30 Day Daily Essentials Duo14 g in 1 TUBEGEL14 g2 g in 100g3
81252-1000-1ENVIO 30 Day Daily Essentials Duo1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81252-0101ENVIO 30 DAY DAILY ESSENTIALS DUO (BENZOYL PEROXIDE AND SALICYLIC ACID) KIT [SMART SKIN HEALTH, LLC]3Unmatched20230112_76e1674f-eab8-4798-8b80-2974a5f5c086.zip
81252-0201ENVIO 30 DAY DAILY ESSENTIALS DUO (BENZOYL PEROXIDE AND SALICYLIC ACID) KIT [SMART SKIN HEALTH, LLC]3Unmatched20230112_76e1674f-eab8-4798-8b80-2974a5f5c086.zip
81252-1000ENVIO 30 DAY DAILY ESSENTIALS DUO (BENZOYL PEROXIDE AND SALICYLIC ACID) KIT [SMART SKIN HEALTH, LLC]3Legacy NDC, 3 package rows20230112_76e1674f-eab8-4798-8b80-2974a5f5c086.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 54 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81252-100081252-1000-1
81252-010181252-0101-1
81252-020181252-0201-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 64 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzoyl PeroxideW9WZN9A0GMACTIB
Water059QF0KO0RIACT
Sodium C14-16 Olefin SulfonateO9W3D3YF5UIACT
GlycerinPDC6A3C0OXIACT
Cocamidopropyl Betaine5OCF3O11KXIACT
Cetostearyl Alcohol2DMT128M1SIACT
Glycol Distearate13W7MDN21WIACT
Cetyl Alcohol936JST6JCNIACT
PanthenolWV9CM0O67ZIACT
Aloe Vera LeafZY81Z83H0XIACT
Hyaluronate SodiumYSE9PPT4THIACT
Allantoin344S277G0ZIACT
Ethylhexylglycerin147D247K3PIACT
PhenoxyethanolHIE492ZZ3TIACT
Sodium Hydroxide55X04QC32IIACT
Salicylic AcidO414PZ4LPZACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Decyl GlucosideZ17H97EA6YIACT
Witch Hazel101I4J0U34IACT
Tea Tree OilVIF565UC2GIACT
Allantoin344S277G0ZIACT
PanthenolWV9CM0O67ZIACT
Xanthan GumTTV12P4NEEIACT
Glyceryl Monostearate230OU9XXE4IACT
Glyceryl Stearate CitrateWH8T92A065IACT
Salix Alba Bark205MXS71H7IACT
Green Tea LeafW2ZU1RY8B0IACT
Ethylhexylglycerin147D247K3PIACT
PhenoxyethanolHIE492ZZ3TIACT
Water059QF0KO0RINGR
GlycerinPDC6A3C0OXINGR
BentoniteA3N5ZCN45CINGR
Kaolin24H4NWX5COINGR
Glyceryl RicinoleateZUE0CEL42OINGR
Medium-Chain TriglyceridesC9H2L21V7UINGR
Stearic Acid4ELV7Z65APINGR
Alcohol3K9958V90MINGR
Cetyl Alcohol936JST6JCNINGR
Titanium Dioxide15FIX9V2JPINGR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
04750ce1-a27c-43df-a7bf-ece68646251e76e1674f-eab8-4798-8b80-2974a5f5c0862023-01-06WarningsExact identifier
spl id: 04750ce1-a27c-43df-a7bf-ece68646251e
spl set id: 76e1674f-eab8-4798-8b80-2974a5f5c086

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.