FDA.reportPublic FDA data

Top Care 619.003/619AC rev 2 Daily Moisturizing Lotion

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:44:12

Label at a glance#

ProductDaily Moisturizing
Active ingredientDIMETHICONE
Label structure13 sections

Indications and uses

helps prevent and temporarily protects chafed, chapped or cracked skin helps protect from the drying effects of wind and cold weather

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Claim

SPL UNCLASSIFIED SECTION

TopCare

beauty

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.3%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps prevent and temporarily protects chafed, chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens 
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

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 as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, Avena sativa (oat) kernel flour, benzyl alcohol, sodium chloride

ADVERSE REACTION

ADVERSE REACTIONS SECTION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Aveeno ®Daily Moisturizing Lotion

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007 ©TOPCO VIJA0519

QUESTIONS? 1-888-423-0139 topcare@topco.com www.topccarebrand.com

Visit here for more information:

topbrnds.com/48ztgy

QUALITY GUARANTEED

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOPCARE

beauty™

DAILY MOISTURIZING LOTION

Dimethicone Skin Protectant

Compare to AVEENO ®*

With natural colloidal oatmeal

Dermatologist tested

Fragrance Free

12 FL OZ (354 mL)

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891710dimethicone 1.3 % Topical LotionPSN16
891710dimethicone 13 MG/ML Topical LotionSCD16
891710dimethicone 1.3 % Topical LotionSY16

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-619-40Daily Moisturizing354 mL in 1 BOTTLE, PUMPLOTION35416
36800-619-44Daily Moisturizing532 mL in 1 BOTTLE, PUMPLOTION53216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
DISTEARYLDIMONIUM CHLORIDEINACTIVE INGREDIENTOM9573ZX3X1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M1
OATMEALINACTIVE INGREDIENT8PI54V663Y1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-61936800-619-40, 36800-619-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
OATMEAL8PI54V663YIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM CHLORIDE451W47IQ8XIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
Daily MoisturizingDIMETHICONETopco Associates LLC47e54eee-70e0-4bfa-ae77-d61a6560a9e12026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 36800-619-40
ndc (package): 36800-619-44
ndc (product): 36800-619
ndc11 (package): 36800061944
ndc11 (package): 36800061940
spl id: 4ab9a518-a4b1-4f35-e063-6294a90a043c
spl set id: 47e54eee-70e0-4bfa-ae77-d61a6560a9e1

Reported adverse events (FAERS/openFDA)#

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