Label: UNIVERSAL GLOW DAILY DEFENSE SPF 40- zinc oxide cream
- NDC Code(s): 71501-1903-1
- Packager: Dr. Loretta, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 4, 2023
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- ACTIVE INGREDIENT
- PURPOSE
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Inactive Ingredients
Aqua (Water/Eau), 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, Phenoxyethanol, Tapioca Starch Polymethylsilsesquioxane, Propylene Carbonate, Polysilicone-11, Butyrospermum Parkii (Shea) Butter, Ectoin, Glycerin, Polyglyceryl-10 Laurate, Tromethamine, Ethylhexylglycerin, Octyldodecanol, Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens (Rose Geranium) Flower Oil, Decyl Glucoside, Dimethylmethoxy Chromanol, Sodium Benzoate, Betula Alba Bark Extract, Boswellia Serrata Extract, Polygonum Cuspidatum Root Extract, Caprylyl Glycol, Hexylene Glycol, Jojoba Esters, Trihydroxystearin, Alumina, Centella Asiatica Extract, Tocopherol, Silica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492, CI 77491).
- WARNINGS
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UNIVERSAL GLOW DAILY DEFENSE SPF 40
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71501-1903 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 170 mg in 1 mL Inactive Ingredients Ingredient Name Strength TROMETHAMINE (UNII: 023C2WHX2V) LAVENDER OIL (UNII: ZBP1YXW0H8) ALUMINUM OXIDE (UNII: LMI26O6933) ISODODECANE (UNII: A8289P68Y2) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) ETHYLHEXYL PALMITATE (UNII: 2865993309) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PHENOXYETHANOL (UNII: HIE492ZZ3T) SHEA BUTTER (UNII: K49155WL9Y) ECTOINE (UNII: 7GXZ3858RY) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) FERRIC OXIDE RED (UNII: 1K09F3G675) PROPANEDIOL (UNII: 5965N8W85T) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) OCTYLDODECANOL (UNII: 461N1O614Y) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G) POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) STARCH, TAPIOCA (UNII: 24SC3U704I) BETULA PUBESCENS BARK (UNII: 3R504894L9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71501-1903-1 50 mL in 1 TUBE; Type 0: Not a Combination Product 05/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/01/2023 Labeler - Dr. Loretta, LLC (609417121) Registrant - Dr. Loretta, LLC (609417121)
