RUBELLI WATER GLOW SUN FOR GOLF by RUBELLI CO.,LTD / WINNOVA Co., Ltd.

RUBELLI WATER GLOW SUN FOR GOLF by

Drug Labeling and Warnings

RUBELLI WATER GLOW SUN FOR GOLF 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]

RUBELLI WATER GLOW SUN FOR GOLF- ethylhexyl methoxycinnamate, homosalate, ethylhexyl salicylate, titanium dioxide cream 
RUBELLI CO.,LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS

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

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

Sunscreen

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.

KEEP OUT OF REACH OF CHILDREN

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

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

RUBELLI WATER GLOW SUN FOR GOLF 
ethylhexyl methoxycinnamate, homosalate, ethylhexyl salicylate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71006-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 50 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	1.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.5 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.83 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Pentylene Glycol (UNII: 50C1307PZG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71006-110-02	1 in 1 CARTON	04/01/2021	05/01/2021
1	NDC: 71006-110-01	50 mL in 1 CONTAINER; 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	04/01/2021	05/01/2021

Labeler - RUBELLI CO.,LTD (689452000)

Registrant - RUBELLI CO.,LTD (689452000)

Establishment
Name	Address	ID/FEI	Business Operations
WINNOVA Co., Ltd.		689348571	manufacture(71006-110)

Revised: 6/2021

Document Id: 2f4d964f-cf71-4c1b-a29b-1f2a638ea38e

34390-5

Set id: 49f521d2-5232-4511-aec5-d70454d9bbfe

Version: 2

Effective Time: 20210604