RUBELLI WATER GLOW SUN- octinoxate, 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5.0%, Titanium Dioxide 4.0%

INACTIVE INGREDIENT

Inactive ingredients: Water, Glycerin, Isoamyl p-Methoxycinnamate, Butylene Glycol, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Polysorbate 60, Glyceryl Stearate, Cetearyl Alcohol, Sorbitan Stearate, VP/Eicosene Copolymer, Stearic Acid, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Ethylhexylglycerin, Caprylyl Glycol, Phenoxyethanol, Fragrance, Iron Oxides(CI77492), Tocopheryl Acetate, Polysorbate 80, Centella Asiatica Extract, Magnesium Aluminum Silicate, Iron Oxides(CI77491), Sorbitan Oleate, Iron Oxides(CI77499), Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Tropolone, Sodium Hyaluronate, Disodium EDTA, Caprylyl Glycol, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only 1. Please consult with a physician or other qualified health provider if you have abnormal symptoms such as red spot, swelling or itching, or side effects caused by exposure to direct sunlight, during or after use of the product,. 2. Avoid areas with wounds or other sensitive areas. 3. Precautions for storage and handling. Keep out of reach of children. Avoid direct exposure to sunlight.

DESCRIPTION

Uses: UV protection functional cosmetics with SPF40, PA++ which double-blocks ultraviolet UVA and UVB, and moisturizes the skin without tightness and has a refreshing feeling. In addition, it covers the skin tone with a gentle coverage without cloudiness and makes the skin beautiful that emits a radiant shine. BSASM™(Asiatic pennywort, Asiatic knotweed, Scutellaria baicalensis, green tea, licorice, chamomile flowers, rosemary leaf extract) 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 an appropriate amount over the skin and evenly spread it.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RUBELLI WATER GLOW SUN 
octinoxate, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71006-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.0 g  in 40 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.0 g  in 40 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.6 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71006-050-02	1 in 1 CARTON	06/01/2017
1	NDC: 71006-050-01	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	06/01/2017

Labeler - RUBELLI CO.,LTD (689452000)

Registrant - RUBELLI CO.,LTD (689452000)

Establishment
Name	Address	ID/FEI	Business Operations
RUBELLI CO.,LTD		689452000	manufacture(71006-050)