MANIA HOLIC SUNSCREEN PACK- octocrylene, homosalate, octisalate, avobenzone cream

Mania Holic Sunscreen Pack by

Drug Labeling and Warnings

Mania Holic Sunscreen Pack by is a Otc medication manufactured, distributed, or labeled by Firstmarket Co., ltd., Rebom Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. avoid excessive rubbing during application, as it may result in clumping or uneven texture, for makeup application, allow it to completely dry for one minute, best results when applied over base makeup.
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 of higher and other sun protection measures including: Limited time in the sun, especially from 10 am to 2 pm, Wear long-sleeve shirts, pants, hats, and sunglasses. reapply at least every 2 hours, use a water-resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor

ACTIVE INGREDIENT

Octocrylene 9%

Homosalate 7.2%

Octisalate 4.8%

Avobenzone 2.8%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

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.

Stop using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water, Cellulose, Butyloctyl Salicylate, Silica, Dipropylene Glycol, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Benzyl Glycol, Polysorbate 80, Glyceryl Stearate, Polymethylsilsesquioxane, PEG-100 Stearate, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Poly C10-30 Alkyl Acrylate, Xanthan Gum, Ethylhexylglycerin, Adenosine, 1,2-Hexanediol, Sodium Hyaluronate, Hydrolyzed Hyaluronic Acid, Sodium Acetylated Hyaluronate, Fragrance

OTHER SAFETY INFORMATION

Store away from direct sunlight.

Keep the lid closed when not in use.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MANIA HOLIC SUNSCREEN PACK 
octocrylene, homosalate, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83888-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	72 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
NIACINAMIDE (UNII: 25X51I8RD4)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
ARGININE (UNII: 94ZLA3W45F)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83888-001-02	1 in 1 CARTON	05/19/2024
1	NDC: 83888-001-01	50 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 83888-001-03	1 in 1 PACKAGE	10/23/2024
2	NDC: 83888-001-01	50 g in 1 CONTAINER; 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	05/19/2024

Labeler - Firstmarket Co., ltd. (688288012)

Registrant - Firstmarket Co., ltd. (688288012)

Establishment
Name	Address	ID/FEI	Business Operations
Rebom Co., Ltd.		695951708	manufacture(83888-001)