WATERFUL SUN- ethylhexyl methoxycinnamate, octocrylene, ethylhexyl salicylate, butyl methoxydibenzoylmethane gel

Waterful Sun by

Drug Labeling and Warnings

Waterful Sun by is a Otc medication manufactured, distributed, or labeled by ARI&J Inc, Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

INACTIVE INGREDIENT

Water, Butylene Glycol, etc

PURPOSE

• Suncreen
• protects skin from UV rays
• 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

KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children

INDICATIONS & USAGE

apply generously 15 minutes before sun sxposure

reapply:

• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every two hours

Sun Protection Measures. Spending thime 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, expecially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

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.
• do not place this product in this container in the excessive heat and direct sun.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WATERFUL SUN 
ethylhexyl methoxycinnamate, octocrylene, ethylhexyl salicylate, butyl methoxydibenzoylmethane gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71496-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	4 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71496-0003-1	50 mL in 1 TUBE; Type 0: Not a Combination Product	06/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/30/2017

Labeler - ARI&J Inc (694174441)

Registrant - ARI&J Inc (694174441)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmecca Korea Co., Ltd.		688830827	manufacture(71496-0003)

Establishment
Name	Address	ID/FEI	Business Operations
ARI&J Inc		694174441	label(71496-0003) , pack(71496-0003)