RUBELLI WATER GLOW SUN- octinoxate, homosalate, octisalate, titanium dioxide cream

Rubelli Water Glow Sun by

Drug Labeling and Warnings

Rubelli Water Glow Sun by is a Otc medication manufactured, distributed, or labeled by RUBELLI CO.,LTD, WINNOVA Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients:

Ethylhexyl Methoxycinnamate 7.0%
Homosalate 3.0%
Ethylhexyl Salicylate 3.0%
Titanium Dioxide 1.66%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Butylene Glycol, Pentylene Glycol, Isononyl Isononanoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Niacinamide, Cocoglycerides, Ethylhexyl Triazone, Methyl Methacrylate Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyglyceryl-10 Laurate, Caprylyl Glycol, Polyglyceryl-10 Myristate, Aluminum Hydroxide, Stearic Acid, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Tocopheryl Acetate, Ethylhexylglycerin, Allantoin, Isohexadecane, Xanthan Gum, Sorbitan Isostearate, Adenosine, Polysorbate 80, 1,2-Hexanediol, Tulipa Gesneriana Flower Extract, Viola Mandshurica Flower Extract, Bellis Perennis (Daisy) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Iris Versicolor Extract, Glycerin, Sorbitan Oleate, Biosaccharide Gum-4
Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Polygonum Cuspidatum Root Extract, Aloe Barbadensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Fragrance

PURPOSE

Purpose: Sunscreen

WARNINGS

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

DESCRIPTION

Uses:

Helps prevent sunburn. UV protection functional cosmetics with SPF50+, PA++++ which double-blocks ultraviolet UVA and UVB, and moisturizes the skin without tightness and has a refreshing feeling. BSASM™ which is seven plant complex patented ingredients are added, which calms down the skin tired by ultraviolet rays and makes the skin healthy.

Directions:

Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RUBELLI WATER GLOW SUN 
octinoxate, homosalate, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71006-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.80 g  in 40 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	1.20 g  in 40 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	1.20 g  in 40 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.66 g  in 40 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: 71006-080-02	1 in 1 CARTON	03/01/2019
1	NDC: 71006-080-01	40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2019

Labeler - RUBELLI CO.,LTD (689452000)

Registrant - RUBELLI CO.,LTD (689452000)

Establishment
Name	Address	ID/FEI	Business Operations
WINNOVA Co., Ltd.		689348571	manufacture(71006-080)