ROSILLIANCE MEDIUM/DARK SPF 30 BROAD SPECTRUM- sunscreen liquid

Rosilliance Medium/Dark by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

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 swiming or sweating
• immediately after towel drying
• at least every 2 hours

Sun Protection Measures. Spending time 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 of 15 or higher and other sun protection measures including:

• limit time in the sun especially from 10am-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, Citrus Aurantium Dulcis (ORGANIC Orange) 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, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides, Octyldodecyl Oleate, Oryza Sativa (ORGANIC Rise) Bran Oil, Plankton Extract, Propanediol, Rosa Samascena Leaf Cell Extract, ROsmarinus Officinalis (ORGANIC Rosemary) 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 MEDIUM/DARK  SPF 30 BROAD SPECTRUM
sunscreen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76150-159
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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ORANGE (UNII: 5EVU04N5QU)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER SEED (UNII: R9N3379M4Z)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
RICE BRAN OIL (UNII: LZO6K1506A)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPANEDIOL (UNII: 5965N8W85T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CUCUMBER (UNII: YY7C30VXJT)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
ACAI OIL (UNII: Z0W6766A2W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SAFFLOWER OIL (UNII: 65UEH262IS)
ROSEMARY (UNII: IJ67X351P9)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76150-159-33	45 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2016

Labeler - Bell International Laboratories, Inc (967781555)