BODY GLAZE ESSENCE SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

Body Glaze Essence Sunscreen by

Drug Labeling and Warnings

Body Glaze Essence Sunscreen 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 2.8%

Homosalate 7.2%

Octisalate 4.7%

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.

WARNINGS

● Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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. Rub in.

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

● Do not apply in windy conditions

● Use in a well-ventilated area

● 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

Water, Butyloctyl Salicylate, Niacinamide, Caprylyl Methicone, Dipropylene Glycol, Cetearyl Glucoside, Poly C10-30 Alkyl Acrylate, Sorbitan Olivate, Polysorbate 80, Benzyl Glycol, Cetearyl Alcohol, Glyceryl Stearate SE, Cetyl PEG/PPG-10/ Dimethicone, Polymethylsilsesquioxane, Dicaprylyl Carbonate, Panthenol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Methylpropanediol, Ethylhexylglycerin, Squalane, Polyacrylate Crosspolymer-6, Tocophyeryl Acetate, Butylene Glycol, Caprylyl Glycol, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, 1,2-Hexanediol, Adenosine, Oryza Sativa (Rice) Extract, Opuntia Ficus-Indica Fruit Extract, Steareth-30, Tocopherol, Sodium Hyaluronate, Fragrance, CI 77019, CI 77491

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BODY GLAZE ESSENCE SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84326-824
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	4.7 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ARGININE (UNII: 94ZLA3W45F)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SQUALANE (UNII: GW89575KF9)
NIACINAMIDE (UNII: 25X51I8RD4)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
RICE GERM (UNII: 7N2B70SFEZ)
STEARETH-30 (UNII: 5776GCL1DG)
TOCOPHEROL (UNII: R0ZB2556P8)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CI 77491 (UNII: 1K09F3G675)
XANTHAN GUM (UNII: TTV12P4NEE)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PANTHENOL (UNII: WV9CM0O67Z)
ADENOSINE (UNII: K72T3FS567)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
BENZYL GLYCOL (UNII: 06S8147L47)
PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYMETHYLSILSESQUIOXANE (UNII: 59Z907ZB69)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84326-824-01	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(84326-824)