UNIVERSAL GLOW DAILY DEFENSE SPF 40- zinc oxide cream 
Dr. Loretta, LLC

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.

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Universal Glow Daily Defense SPF 40

Zinc Oxide 17%

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).

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.

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

Helps prevent suburn

Principle display Panel

UNIVERSAL GLOW DAILY DEFENSE SPF 40 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71501-1903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID170 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71501-1903-150 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02005/01/2023
Labeler - Dr. Loretta, LLC (609417121)
Registrant - Dr. Loretta, LLC (609417121)

Revised: 5/2023
Document Id: fae21e0a-5e42-bffb-e053-6294a90afb9d
Set id: fae21e0a-5e41-bffb-e053-6294a90afb9d
Version: 1
Effective Time: 20230504
 
Dr. Loretta, LLC