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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ESPOIR WATER SPLASH SUN SERUM Broad Spectrum SPF 50+

Drug Facts

Active ingredients

Avobenzone 3.0%

Homosalate 9.5%

Octisalate 4.5%

Octocrylene 5.0%

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

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.

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.

■ Reapply at least every 2 hours.

■ Use a water resistant sunscreen if swimming or sweating.

■ 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.

Other information

■ Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

WATER, 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

Questions?

Visit www.espoir.com or
ESPOIRMALL@ESPOIR.COM

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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	95 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHYTATE (UNII: 88496G1ERL)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
ALCOHOL 95% (UNII: 7528N5H79B)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
XYLITOL (UNII: VCQ006KQ1E)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
CARNOSINE (UNII: 8HO6PVN24W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAFFEINE (UNII: 3G6A5W338E)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SODIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: NG5NG5733T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84469-721-02	5 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/02/2024	12/01/2025
2	NDC: 84469-721-01	1 in 1 BOX	09/02/2024
2		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 84469-721-03	2 in 1 BLISTER PACK	12/01/2025
3		1 in 1 BOX
3		50 mL in 1 BOTTLE, PUMP; 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	09/02/2024

Labeler - ESPOIR Corporation (689514335)