FDA.reportPublic FDA data

P.O.V. Baby Moisturizing Fragrance Free

Manufacturer
Apollo Health and Beauty Care Inc.
Effective date
2017-11-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:05

Label at a glance#

ProductP.O.V. Baby Moisturizing Fragrance Free
Active ingredientDIMETHICONE
Label structure8 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked skin, and helps protect from the drying effects of wind and cold.

Dosage and administration

apply as needed.

Storage and handling

store at room temperature.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

temporarily protects and helps relieve chapped or cracked skin, and helps protect from the drying effects of wind and cold.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if irritation or redness develops and lasts more than 7 days, or clears up and recurs within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed.

Other information

STORAGE AND HANDLING SECTION

store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Petrolatum, Isopropyl Palmitate, Distearyldimonium Chloride, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Sodium Chloride, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-695-3030

Label Copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the labelImage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876980dimethicone 1.2 % Topical LotionPSN1
876980dimethicone 12 MG/ML Topical LotionSCD1
876980dimethicone 1.2 % Topical LotionSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130067153949082GTIN-13: 0067153949082
EAN-13: 0067153949082
GTIN-12: 067153949082
UPC-A: 067153949082
GTIN storage (14 digits): 00067153949082		22863L.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-319-182024-01-30C16284748780-11030e365-4ce3-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-319-18P.O.V. Baby Moisturizing Fragrance Free532 mL in 1 BOTTLE, PLASTICLOTION5321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-319P.O.V. BABY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 1 package rows20171127_fe92bccb-48eb-4277-bf5d-3c298304cd09.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63148-31963148-319-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
CETYL ALCOHOL936JST6JCNIACT
OATMEAL8PI54V663YIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
f8cc4e42-599c-41bd-8c05-7f98d3ceffc0fe92bccb-48eb-4277-bf5d-3c298304cd092017-11-27WarningsExact identifier
spl id: f8cc4e42-599c-41bd-8c05-7f98d3ceffc0
spl set id: fe92bccb-48eb-4277-bf5d-3c298304cd09

Reported adverse events (FAERS/openFDA)#

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