PAUL FRANK SUNNY DEFENSE SPF STICK- avobenzone, homosalate, octisalate, octocrylene stick

Paul Frank Sunny Defense SPF Stick by

Drug Labeling and Warnings

Paul Frank 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 damaged or broken skin

WHEN USING

this product ● 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.

STOP USE

and ask a doctor if rash occurs.

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 sweating.

● 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 with a Broad Spectrum SPF of 15 or higher and 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAUL FRANK SUNNY DEFENSE SPF STICK 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84326-624
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.71 g  in 18 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.45 g  in 18 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.81 g  in 18 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	1.71 g  in 18 g

Inactive Ingredients
Ingredient Name	Strength
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
DIMETHYLSILANOL HYALURONATE (UNII: Z853O1D4TE)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HYALURONIC ACID (UNII: S270N0TRQY)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALLANTOIN (UNII: 344S277G0Z)
SYNTHETIC WAX (1900 MW) (UNII: 5M631N9V0S)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84326-624-02	1 in 1 BOX	11/05/2024
1	NDC: 84326-624-01	18 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	11/05/2024

Labeler - RBGROUP Co., Ltd (987610097)

Establishment
Name	Address	ID/FEI	Business Operations
reBom Co., Ltd		695951708	manufacture(84326-624)