SIYAMAYA - BOO BOO MAGIC SPRAY (73531-101) - DELIST

BOO BOO MAGIC by

Drug Labeling and Warnings

BOO BOO MAGIC by is a Otc medication manufactured, distributed, or labeled by Siyamaya Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOO BOO MAGIC- dimethicone, zinc oxide spray 
Siyamaya Brands 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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SIYAMAYA - BOO BOO MAGIC SPRAY (73531-101) - DELIST

ACTIVE INGREDIENTS

Dimethicone 20%

Zinc Oxide 25%

PURPOSE

Skin Protectant

USES

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

WARNINGS

• 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

• 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

• 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

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

INACTIVE INGREDIENTS

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.

BOO BOO MAGIC 
dimethicone, zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73531-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 g  in 100 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
LANOLIN (UNII: 7EV65EAW6H)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
CALOPHYLLUM INOPHYLLUM LEAF (UNII: 9156W5K2Z7)
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
VITAMIN D3 RECEPTOR (UNII: UD6C4246PU)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
OENOTHERA BIENNIS (UNII: 76UI55V071)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73531-101-12	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2021	12/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/17/2021	12/29/2022

Labeler - Siyamaya Brands LLC (117356202)

Revised: 12/2022

Document Id: f0fcacf5-f01b-2705-e053-2995a90a4547

34390-5

Set id: 4deaadf3-3c90-46a0-b2a3-7e87571fa622

Version: 4

Effective Time: 20221229