FDA.reportPublic FDA data

SIYAMAYA - BOO BOO MAGIC SPRAY - DIAPER RASH SPRAY(73531-101)

Manufacturer
Siyamaya Brands LLC
Effective date
2022-03-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:04:57

Label at a glance#

ProductBOO BOO MAGIC
Active ingredientZINC OXIDE, DIMETHICONE
Label structure8 sections

Indications and uses

Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

change wet and soiled diapers promptly cleanse diaper area and allow to dry Shake bottle well before use To open, twist lock to the left To close, push lock up and twist to the right. Re-lock after each use Spray 2-4 inches from skin No rub-in is required Apply liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposed to to wet diapers may be prolonged.

Storage and handling

Store between 59 degrees-86 degrees fahrenheit (15 degrees-30 degrees celsius) Do not use if safety seal is missing or broken

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 20%

Zinc Oxide 25%

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

USES

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness

WARNINGS

WARNINGS SECTION

  • For external use only
  • When using this product
  • do not get into eyes. If contacts occures, rinse eyes thoroughly with water.
  • Stop use and ask doctor if
  • conditions worsens
  • symptoms last more than 7 days or clear up and occur again again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of childeren. If swollowed, ge medical help or contact a poison control center right away
  •      Lock when not in use

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • change wet and soiled diapers promptly
  • cleanse diaper area and allow to dry
  • Shake bottle well before use
  • To open, twist lock to the left
  • To close, push lock up and twist to the right.
  • Re-lock after each use
  • Spray 2-4 inches from skin
  • No rub-in is required
  • Apply liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposed to to wet diapers may be prolonged.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Store between 59 degrees-86 degrees fahrenheit (15 degrees-30 degrees celsius)
  • Do not use if safety seal is missing or broken

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Lanolin, Tocopheryl Acetate (Vitamin E), Glycerin, Calophyllum Inophyllum (Tamanu) Seed Oil, Argania Spinosa (Argan) Kernel Oil, Light Mineral Oil, Vitamin A Palmitate, Vitamin D3, Olea Europaea (Olive) Fruit Oil, Chamomilla Recutita (Matricaria) Flower Oil, Oenothera Biennis (Evening Primsose) Oil.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b_LBL_SiyaMiya_Diaper Spray01b_LBL_SiyaMiya_Diaper Spray

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73531-101-122022-12-29C16284748780-1e4f33bdf-a318-d8a0-e053-dadaa90a6e4eSIYAMAYA - BOO BOO MAGIC SPRAY - DIAPER RASH SPRAY(73531-101)
73531-101-122022-07-29C16284748780-1e4f33bdf-a318-d8a0-e053-dadaa90a6e4eSIYAMAYA - BOO BOO MAGIC SPRAY - DIAPER RASH SPRAY(73531-101)

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73531-10173531-101-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
LANOLIN7EV65EAW6HIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
CALOPHYLLUM INOPHYLLUM LEAF9156W5K2Z7IACT
ARGANIA SPINOSA SEED8H7X7XB54HIACT
LIGHT MINERAL OILN6K5787QVPIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
VITAMIN D3 RECEPTORUD6C4246PUIACT
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLESXO45V955LTIACT
MATRICARIA CHAMOMILLA FLOWERING TOP OILSA8AR2W4ERIACT
OENOTHERA BIENNIS76UI55V071IACT
ZINC OXIDESOI2LOH54ZACTIM
DIMETHICONE92RU3N3Y1OACTIB

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
f0fcacf5-f01b-2705-e053-2995a90a45474deaadf3-3c90-46a0-b2a3-7e87571fa6222022-12-29WarningsExact identifier
spl set id: 4deaadf3-3c90-46a0-b2a3-7e87571fa622

Reported adverse events (FAERS/openFDA)#

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