Label: COOLA ROSILLIANCE MINERAL TINTED FACE MOISTURIZER SPF 30 GOLDEN HOUR- titanium dioxide lotion
- NDC Code(s): 79753-047-01
- Packager: COOLA, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 2, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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
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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.
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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, Caprylhydroxamic Acid, Sodium Citrate, Hydrogen Dimethicone, Flavor
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLA ROSILLIANCE MINERAL TINTED FACE MOISTURIZER SPF 30 GOLDEN HOUR
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-047 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) 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) ROSA CENTIFOLIA WHOLE (UNII: FQ84CRP97P) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) PROPANEDIOL (UNII: 5965N8W85T) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ROSA DAMASCENA FLOWER (UNII: JWB78P295A) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ROSA GALLICA FLOWER (UNII: X8W61WUV70) GLYCERIN (UNII: PDC6A3C0OX) COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7) SUNFLOWER SEED (UNII: R9N3379M4Z) SODIUM CITRATE (UNII: 1Q73Q2JULR) ACAI OIL (UNII: Z0W6766A2W) SUNFLOWER OIL (UNII: 3W1JG795YI) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) COCO-GLYCERIDES (UNII: ISE9I7DNUG) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) RICE BRAN OIL (UNII: LZO6K1506A) 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) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-047-01 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)