JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREEN- homosalate, octisalate, octocrylene, titanium dioxide cream

JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREEN by

Drug Labeling and Warnings

JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by GPNY CORP, Rebom Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 12.6 %
Octisalate 5.0 %
Octocrylene 8.7 %
Titanium Dioxide 1.8 %

Purpose

sunscreen

Uses

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 skin or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ apply liberally 15 minutes before sun exposure
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 value 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-sleeved shirts, pants, hats, and sunglasses
■ children under 6 months of age: Ask a doctor
■ reapply at least every 2 hours
■ use a water-resistant sunscreen if swimming or sweating

Other information

■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Water, Butyloctyl Salicylate, Polymethylsilsesquioxane, Cetearyl Glucoside, Benzyl Glycol, Glyceryl Stearate SE, Sorbitan Olivate, Poly C10-30 Alkyl Acrylate, Arginine, Butylene Glycol, Silica, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Polysorbate 60, Oleth-10, 1,2-Hexanediol, Dimethicone, Panthenol, Cetearyl Alcohol, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Ethylhexylglycerin, Glutathione, Niacinamide, Ceramide NP, Zinc PCA, Tocopherol, Glyceryl Glucoside, Glycerin, Sodium Hyaluronate, Centella Asiatica Extract, Fragrance, Linalool, Limonene

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREEN 
homosalate, octisalate, octocrylene, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84754-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.35 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.9 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.3 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PANTHENOL (UNII: WV9CM0O67Z)
ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)
CERAMIDE NP (UNII: 4370DF050B)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
DIMETHICONE (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)
NIACINAMIDE (UNII: 25X51I8RD4)
WATER (UNII: 059QF0KO0R)
SORBITAN OLIVATE (UNII: MDL271E3GR)
POLYSORBATE 60 (UNII: CAL22UVI4M)
OLETH-10 (UNII: JD797EF70J)
GLUTATHIONE (UNII: GAN16C9B8O)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
ARGININE (UNII: 94ZLA3W45F)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ZINC PIDOLATE (UNII: C32PQ86DH4)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84754-051-02	1 in 1 BOX	11/07/2024
1		50 mL in 1 TUBE; 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	11/07/2024

Labeler - GPNY CORP (108497367)

Establishment
Name	Address	ID/FEI	Business Operations
Rebom Co., Ltd.		695951708	manufacture(84754-051)