COOLA ROSILLIANCE MINERAL TINTED FACE MOISTURIZER SPF 30 FRESH ROSE- titanium dioxide lotion

COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh Rose by

Drug Labeling and Warnings

COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh Rose by is a Otc medication manufactured, distributed, or labeled by COOLA, LLC. 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 a doctor if skin rash occurs.

KEEP OUT OF REACH OF CHILDREN

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 Measure: 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 value of 15 or higher and other sun protection measures including:
  Limit time in the sun, especially from 10 a.m. to 2 p.m.
  Wear long-sleeved shirts, pants, hats, and sun glasses.

INACTIVE INGREDIENT

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

OTHER SAFETY INFORMATION

• Protect this product from excessive heat and direct sun

QUESTIONS

Call 760-940-2125

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOLA ROSILLIANCE MINERAL TINTED FACE MOISTURIZER SPF 30 FRESH ROSE 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-046
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
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ROSEMARY (UNII: IJ67X351P9)
XANTHAN GUM (UNII: TTV12P4NEE)
ORANGE (UNII: 5EVU04N5QU)
ROSA X ALBA FLOWER OIL (UNII: FF1Y064QVO)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SAFFLOWER OIL (UNII: 65UEH262IS)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PROPANEDIOL (UNII: 5965N8W85T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ROSA CENTIFOLIA WHOLE (UNII: FQ84CRP97P)
ACAI OIL (UNII: Z0W6766A2W)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CUCUMBER (UNII: YY7C30VXJT)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
RICE BRAN OIL (UNII: LZO6K1506A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ROSA GALLICA FLOWER (UNII: X8W61WUV70)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
MICA (UNII: V8A1AW0880)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
GLYCERIN (UNII: PDC6A3C0OX)
COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7)
SUNFLOWER SEED (UNII: R9N3379M4Z)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-046-01	1 in 1 CARTON	01/01/2017
1		44 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2017

Labeler - COOLA, LLC (956990290)