Label: FRUDIA BLUEBERRY HYDRATING AIR FIT SUNSCREEN- octocrylene, homosalate, octisalate, avobenzone cream
- NDC Code(s): 71017-001-01, 71017-001-02
- Packager: WELCOS CO.,LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 27, 2024
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DOSAGE & ADMINISTRATION
- 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 - ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
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
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FRUDIA BLUEBERRY HYDRATING AIR FIT SUNSCREEN
octocrylene, homosalate, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71017-001 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 73 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 47 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 27 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:71017-001-02 1 in 1 CARTON 04/27/2024 1 NDC:71017-001-01 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 04/27/2024 Labeler - WELCOS CO.,LTD. (689131584) Registrant - WELCOS CO.,LTD. (689131584) Establishment Name Address ID/FEI Business Operations Rebom Co., Ltd. 695951708 manufacture(71017-001)