ROSILLIANCE GOLDEN TINT SPF 30 BROAD SPECTRUM- sunscreen lotion

Rosilliance Golden Tint by

Drug Labeling and Warnings

Rosilliance Golden Tint by is a Otc medication manufactured, distributed, or labeled by Bell International Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 5.6%

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 doctor if skin rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure

reapply:

• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

Sun Protection Measures. Spending time int he sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

• limit time in the sun speially from10am-2pm
• wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

Inactive ingredients

Aluminum Hydroxide, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (ORGANIC Safflower) Seed Oil, Cirtus Aurantium Dulcis (ORGANIC Orange0 Fruit Water, Cocoglycerides, Commiphora Myrrha Leaf Cell Extract, Cucumis Sativus (ORGANIC Cucumber) Fruit Extract, Dicaprylyl Carbonate, Euterpe Oleracea Pulp Oil (ORGANIC), Flavor, Glycerin (ORGANIC), Helianthus Annuus (ORGANIC Sunflower) Seed Extract, Helianthus Annuus (ORGANIC Sunflower) Seed Oil, Hydrogen Dimethicone, Hydrolyzed Wheat Protein/PVP Crosspolymer, Hyroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides, Octyldodecyl Oleate, Oryza Sativa (ORGANIC Rice) BRan Oil, Plankton Extract, Propanediol, Rosa Alba Leaf Cell Extract, Rosa Centifolia Leaf Cell Extract, ROsa Damascena Leaf Cell Extract, Rosa Gallica Leaf Cell Extract, Rosmarinus Officinalis (ORGANIC Rosemary0 Leaf Extract, SOdium Citrate, Trisodium Ethylenediamine Disuccinate, Water, Xanthan Gum

Other information

protect this product from excessive heat and direct sun

PDP

INGREDIENTS AND APPEARANCE

ROSILLIANCE GOLDEN TINT  SPF 30 BROAD SPECTRUM
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76150-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACAI OIL (UNII: Z0W6766A2W)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
RICE BRAN OIL (UNII: LZO6K1506A)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ORANGE (UNII: 5EVU04N5QU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SUNFLOWER SEED (UNII: R9N3379M4Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
SAFFLOWER OIL (UNII: 65UEH262IS)
ROSEMARY (UNII: IJ67X351P9)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76150-203-33	45 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2017

Labeler - Bell International Laboratories, Inc (967781555)