ROSILLIANCE MEDIUM/DARK SPF 30 BROAD SPECTRUM- sunscreen liquid 
Bell International Laboratories, Inc

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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Coola SPF 30 Rosillance Medium/Dark

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

PDP

ROSILLIANCE MEDIUM/DARK  SPF 30 BROAD SPECTRUM
sunscreen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76150-159
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
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)  
COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
CUCUMBER (UNII: YY7C30VXJT)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
ACAI OIL (UNII: Z0W6766A2W)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
ROSEMARY (UNII: IJ67X351P9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76150-159-3345 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2016
Labeler - Bell International Laboratories, Inc (967781555)

Revised: 1/2021
 
Bell International Laboratories, Inc