UNIVERSAL GLOW DAILY DEFENSE SPF 40- zinc oxide cream

Universal Glow Daily Defense SPF 40 by

Drug Labeling and Warnings

Universal Glow Daily Defense SPF 40 by is a Otc medication manufactured, distributed, or labeled by Dr. Loretta, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 17%

PURPOSE

Sunscreen

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

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 and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Apply liberally and evenly 15 minutes before sun exposure. Reapply at last every 2 hours. Use a water-resistant sunscreen if swimming or sweating.

INDICATIONS & USAGE

Helps prevent suburn

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNIVERSAL GLOW DAILY DEFENSE SPF 40 
zinc oxide cream

Product 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)