MANIA HOLIC SUNSCREEN PACK- octocrylene, homosalate, octisalate, avobenzone cream 
Firstmarket Co., ltd.

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83888-001_Mania Holic Sunscreen Pack

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

Octocrylene 9%

Homosalate 7.2%

Octisalate 4.8%

Avobenzone 2.8%

Sunscreen

Helps prevent sunburn

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

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

Store away from direct sunlight.

Keep the lid closed when not in use.

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MANIA HOLIC SUNSCREEN PACK 
octocrylene, homosalate, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83888-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE90 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE72 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE48 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83888-001-021 in 1 CARTON05/19/2024
1NDC:83888-001-0150 g in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:83888-001-031 in 1 PACKAGE10/23/2024
2NDC:83888-001-0150 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/19/2024
Labeler - Firstmarket Co., ltd. (688288012)
Registrant - Firstmarket Co., ltd. (688288012)
Establishment
NameAddressID/FEIBusiness Operations
Rebom Co., Ltd.695951708manufacture(83888-001)

Revised: 10/2024
Document Id: 252ebace-d540-0bca-e063-6394a90a3010
Set id: b95a460c-1f7b-4193-b305-466e073af640
Version: 3
Effective Time: 20241023
 
Firstmarket Co., ltd.