FRUDIA BLUEBERRY HYDRATING AIR FIT SUNSCREEN- octocrylene, homosalate, octisalate, avobenzone cream 
WELCOS CO.,LTD.

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71017-001_FRUDIA Blueberry Hydrating Air Fit Sunscreen

- Apply liberally 15 minutes before sun exposure. Reapply at least every two hours
- 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: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
- Ask a doctor to use for children under 6 months

Octocrylene 9.00%

Homosalate 7.30%

Octisalate 4.70%

Avobenzone 2.70%

Sunscreen

Helps prevent sunburn

For external use only

Do not use on damaged or broken skin

Stop using and ask a doctor if rash occurs

When using this product, keep out of eyes. Rinse with water to remove.

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

Water, Butyloctyl Salicylate, Niacinamide, Dicaprylyl Carbonate, Dipropylene Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Poly C10-30 Alkyl Acrylate, Sorbitan Olivate, Polymethylsilsesquioxane, Vaccinium Angustifolium (Blueberry) Fruit Extract, Benzyl Glycol, Glyceryl Stearate SE, Panthenol, Carbomer, Arginine, Ganoderma Lucidum (Mushroom) Stem Extract, Tocopheryl Acetate, Glycerin, Glyceryl Glucoside, Disodium EDTA, Ethylhexylglycerin, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Adenosine, Caprylic/Capric Triglyceride, Propanediol, Sodium Hyaluronate Crosspolymer, Hydrogenated lecithin, Hydrolyzed Glycosaminoglycans, 1,2-Hexanediol, Sodium Hyaluronate, Tocopherol, Hydrolyzed Hyaluronic Acid, Phytosterols, Hyaluronic Acid, Fragrance

Protect the product in this container from excessive heat and direct sun

image description

FRUDIA BLUEBERRY HYDRATING AIR FIT SUNSCREEN 
octocrylene, homosalate, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71017-001
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) HOMOSALATE73 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE27 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PANTHENOL (UNII: WV9CM0O67Z)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ARGININE (UNII: 94ZLA3W45F)  
GANODERMA LUCIDUM STEM (UNII: U8PA41532G)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL GLUCOSIDE (UNII: 3297VXM8Z6)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYPROMELLOSE 2208 0.45% STEAROXY ETHER (UNII: MG58AH4FJ8)  
ADENOSINE (UNII: K72T3FS567)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPANEDIOL (UNII: 5965N8W85T)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
HYALURONIC ACID (UNII: S270N0TRQY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71017-001-021 in 1 CARTON04/27/2024
1NDC:71017-001-0150 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/27/2024
Labeler - WELCOS CO.,LTD. (689131584)
Registrant - WELCOS CO.,LTD. (689131584)
Establishment
NameAddressID/FEIBusiness Operations
Rebom Co., Ltd.695951708manufacture(71017-001)

Revised: 4/2024
Document Id: 1713c9a2-8a37-4a3d-e063-6394a90a3b7c
Set id: 8b2a1baa-e528-48d6-9cd8-c3cb55e0641b
Version: 1
Effective Time: 20240427
 
WELCOS CO.,LTD.