LUMINOUS AQUA SUNSCREEN MIST- avobenzone, homosalate, octisalate, octocrylene spray

luminous aqua sunscreen mist by

Drug Labeling and Warnings

luminous aqua sunscreen mist by is a Otc medication manufactured, distributed, or labeled by RBGROUP Co., Ltd, reBom Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 2.5%

Homosalate 9.5%

Octisalate 4.5%

Octocrylene 9.5%

PURPOSE

Sunscreen

INDICATIONS & USAGE

● 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 or broken skin

WHEN USING

this product ● keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

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

STOP USE

and ask a doctor if rash occurs.

DOSAGE & ADMINISTRATION

Directions

● Spray liberally and spread evenly by hand 15 minutes before sun exposure.

● Apply to all skin exposed to the sun.

● Do not spray directly into face.

● Spray on hands and then apply to face. Rub in.

● If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

● Do not apply in windy conditions.

● Reapply at least every 2 hours.

● Children under 6 months of age: Ask a doctor

● 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 or higher and other sun protection measures including: ● Limit time in the sun, especially from 10 a.m.-2 p.m. ● Wear long-sleeve shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT

Alcohol, Isopropyl Myristate, Butyloctyl Salicylate, Acrylates/Octylacrylamide Copolymer, Water, Benzyl Glycol, Ethylhexylglycerin, 1,2-Hexanediol, Glycerin, Butylene Glycol, Sodium Hyaluronate, Ethyl Hexanediol, Centella Asiatica Extract, Madecassic Acid, Asiaticoside, Aslatic Acid, Hydrolyzed Hyaluronic Acid, Sodium Acetylated Hyaluronate, Fragrance

WARNINGS

●Danger : Flammable. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperature below 120ºF(48ºC). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUMINOUS AQUA SUNSCREEN MIST 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84326-724
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.8 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MADECASSIC ACID (UNII: M7O1N24J82)
ALCOHOL (UNII: 3K9958V90M)
BENZYL GLYCOL (UNII: 06S8147L47)
ETHYL HEXANEDIOL (UNII: M9JGK7U88V)
ASIATICOSIDE (UNII: PKO39VY215)
ASIATIC ACID (UNII: 9PA5A687X5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
HYALURONIC ACID (UNII: S270N0TRQY)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84326-724-01	1 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/23/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/23/2024

Labeler - RBGROUP Co., Ltd (987610097)

Establishment
Name	Address	ID/FEI	Business Operations
reBom Co., Ltd		695951708	manufacture(84326-724)