ESPOIR WATER SPLASH SUN SERUM- homosalate, octocrylene, octisalate, avobenzone lotion

ESPOIR WATER SPLASH SUN SERUM by

Drug Labeling and Warnings

ESPOIR WATER SPLASH SUN SERUM by is a Otc medication manufactured, distributed, or labeled by ESPOIR Corporation, COSMAX, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

HOMOSALATE(9.5%) OCTOCRYLENE(5.0%)
OCTISALATE(4.5%) AVOBENZONE(3.0%)

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

• Do not use on damaged or broken skin
• When using this product keep out of eyes. Rinse water to remove
• Stop use and ask do ctor if rash occurs
• Skin Cancer/Skin Aging Alert Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging

Inactive Ingredients

WATER /AQUA/EAU, BUTYLENE GLYCOL, BUTYLOCTYL SALICYLATE, ALCOHOL DENAT, METHYL METHACRYLATE CROSSPOLYMER, 12-HEXANEDIOL, XYLITOL, PENTYLENE GLYCOL, BENZOTRIAZOLYL DODECYL P-CRESOL, DIBUTYL LAUROYL GLUTAMIDE, DIBUTYL ETHYLHEXANOYL GLUTAMIDE, SODIUM ACRYLATES CROSSPOLYMER-2, ETHYLHEXYL METHOXYCRYLENE, C30-45 ALKYLDIMETHYLSILYL POLYPROPYLSILSESQUIOXANE, CAFFEINE, SODIUM POLYACRYLOYLDIMETHYLTAURATE, FRAGRANCE / PARFUM, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, POLYACRYLATE CROSSPOLYMER-6, SODIUM HYALURONATE, BIOSACCHARIDE GUM-1, SODIUM PHYTATE, ETHYLHEXYLGLYCERIN, CARNOSINE

Directions

• Apply generously and evenly 15 minutes before sun exposure
• Children under 6 months of age: Ask a doctor
• For sunscreen use
• Apply to all skin exposed to the sun

Other Information

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

KEEP OUT OF REACH CHILDREN

PACKAGE LABEL Espoir Water Splash Sun Serum_Outer package

INGREDIENTS AND APPEARANCE

ESPOIR WATER SPLASH SUN SERUM 
homosalate, octocrylene, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84469-721
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84469-721-01	1 in 1 BOX	09/02/2024
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 84469-721-02	5 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/02/2024

Labeler - ESPOIR Corporation (689514335)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX, INC.		689049693	manufacture(84469-721)