Label: RADIANT SHIELD BROAD SPECTRUM SPF 40 TINTED MINERAL SUNSCREEN- zinc oxide cream
- NDC Code(s): 70060-1507-1
- Packager: CosMedical Technologies, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 28, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Uses
- Warnings
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Directions
• Apply liberally and evenly 15 minutes before sun exposure. • Reapply: at least every 2 hours • Use a water-resistant sunscreen if swimming or sweating. • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.–2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses • Children under 6 months of age: Ask a doctor.
- Other Information
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Inactive Ingredients
Water (Aqua), Isododecane, Propanediol, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, C12-15 Alkyl Benzoate, Dimethicone, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Coco-Caprylate/Caprate, Ethylhexyl Palmitate, Polymethylsilsesquioxane, Disteardimonium Hectorite, Polyglyceryl-10 Dioleate, Polyhydroxystearic Acid, Lecithin, Ectoin, Dimethylmethoxy Chromanol, Betula Alba (Birch) Bark Extract, Boswellia Serrata (Indian Frankincense) Extract, Polygonum Cuspidatum (Japanese Knotweed) Root Extract, Centella Asiatica (Gotu Kola) Extract, Butyrospermum Parkii (Shea) Butter, Glycerin, Tapioca Starch Polymethylsilsesquioxane, Propylene Carbonate, Polysilicone-11, Tromethamine, Polyglyceryl-10 Laurate, Octyldodecanol, Jojoba Esters, Trihydroxystearin, Alumina, Silica, Phenoxyethanol, Ethylhexylglycerin, Titanium Dioxide (CI 77891), Iron Oxide (CI 77491, CI 77492), Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens (Rose Geranium) Flower Oil.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
RADIANT SHIELD BROAD SPECTRUM SPF 40 TINTED MINERAL SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70060-1507 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 170 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) PROPANEDIOL (UNII: 5965N8W85T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) ETHYLHEXYL PALMITATE (UNII: 2865993309) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX) ECTOINE (UNII: 7GXZ3858RY) DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F) BETULA PUBESCENS BARK (UNII: 3R504894L9) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) SHEA BUTTER (UNII: K49155WL9Y) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE CARBONATE (UNII: 8D08K3S51E) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TROMETHAMINE (UNII: 023C2WHX2V) POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G) OCTYLDODECANOL (UNII: 461N1O614Y) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) LAVENDER OIL (UNII: ZBP1YXW0H8) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70060-1507-1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/02/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/02/2024 Labeler - CosMedical Technologies, LLC (803898329) Establishment Name Address ID/FEI Business Operations CosMedical Technologies, LLC 803898329 label(70060-1507)
