MIFFY SUNNY DEFENSE SPF STICK- homosalate, octocrylene, octisalate, avobenzone stick

Miffy Sunny Defense SPF Stick by

Drug Labeling and Warnings

Miffy Sunny Defense SPF Stick by is a Otc medication manufactured, distributed, or labeled by RBGROUP Co., Ltd, reBom Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 2.5%

Homosalate 9.5%

Octisalate 4.5%

Octocrylene 9.5%

PURPOSE

Sunscreen

INDICATIONS & USAGE

● Helps prevent sunburn.

● If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

For external use only

DO NOT USE

● on damaed skin or broken skin

STOP USE

and ask a doctor if rash occurs.

WHEN USING

● Keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

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

OTHER SAFETY INFORMATION

● Protect this product from excessive heat and direct sun.

DOSAGE & ADMINISTRATION

Directions

● Apply liberally 15 minutes before sun exposure.

● Use a water resistant sunscreen if swimming or swating.

● Reapply at least every 2 hours.

● Children under 6 months of age: Ask a doctor.

● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen other sun protection measures including: ● Limit time in the sun, especially from 10 a.m. - 2 p.m. ● Wear long-sleeve shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT

Ethylhexyl Palmitate, Synthetic Wax, Butyloctyl Salicylate, Dicaprylyl Carbonate, Ethylhexylglycerin, Water, Tocopherol, Allantoin, Butylene Glycol, 1,2-Hexanediol, Centella Asiatica Extract, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Sodium Hyaluronate, Hyaluronic Acid, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate

PDP_Miffy Sunny Defense SPF Stick

INGREDIENTS AND APPEARANCE

MIFFY SUNNY DEFENSE SPF STICK 
homosalate, octocrylene, octisalate, avobenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84326-424
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.55 g  in 22 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.09 g  in 22 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.09 g  in 22 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.99 g  in 22 g

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TOCOPHEROL (UNII: R0ZB2556P8)
DIMETHYLSILANOL HYALURONATE (UNII: Z853O1D4TE)
ALLANTOIN (UNII: 344S277G0Z)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84326-424-02	1 in 1 BOX	10/15/2024
1	NDC: 84326-424-01	22 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/15/2024

Labeler - RBGROUP Co., Ltd (987610097)

Establishment
Name	Address	ID/FEI	Business Operations
reBom Co., Ltd		695951708	manufacture(84326-424)