NDC | 76150-159-33 |
Set ID | 5bd51da9-429e-f670-e053-2a91aa0a95b3 |
Category | HUMAN OTC DRUG LABEL |
Packager | Bell International Laboratories, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredient
- Uses
- Warnings
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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
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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
- PDP
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INGREDIENTS AND APPEARANCE
ROSILLIANCE MEDIUM/DARK SPF 30 BROAD SPECTRUM
sunscreen liquidProduct 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 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 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)