ROSILLANCE LIGHT/MEDIUM SPF 30 BROAD SPECTRUM- sunscreen lotion

Rosillance Light/Medium by

Drug Labeling and Warnings

Rosillance Light/Medium 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 wtih 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 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 o 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, Caprylohydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorium (ORGANIC Safflower) Seed Oil, Citrus Aurantium Dulcis (ORGANIC Orange) Fruit Water, Cocoglycerides, Commiphora Myrrha Leaf Cell Extract, Cucumis Satuvus (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, Mica, Octyldodecyl Oleate, Oryza Sativa (ORGANIC Rise) Bran Oil, Plankton Extract, Rosmarinus Officinalis (ORGANIC Rosemary) Leaf Extrat, Sodium Citrate, Trisodium Ethylenediamine Disuccinate, Water, Xanthan Gum

other information

protect this product from excessive heat and direct sun

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INGREDIENTS AND APPEARANCE

ROSILLANCE LIGHT/MEDIUM  SPF 30 BROAD SPECTRUM
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76150-160
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
CUCUMBER (UNII: YY7C30VXJT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
WATER (UNII: 059QF0KO0R)
ORANGE (UNII: 5EVU04N5QU)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER SEED (UNII: R9N3379M4Z)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
RICE BRAN OIL (UNII: LZO6K1506A)
ACAI OIL (UNII: Z0W6766A2W)
ROSEMARY (UNII: IJ67X351P9)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
SAFFLOWER OIL (UNII: 65UEH262IS)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76150-160-33	45 mL in 1 VIAL, 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)