DR LORETTA UNIVERSAL GLOW DAILY DEFENSE SPF 40- zinc oxide cream

Dr Loretta Universal Glow Daily Defense SPF 40 by

Drug Labeling and Warnings

Dr Loretta 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]

Drug Facts

Active Ingredient

Zinc Oxide 17%

Purpose

Sunscreen

Uses

Helps prevent sunburn

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 use 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.

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

Protect the product in this container from excessive heat and direct sun.

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, Propylene Carbonate, Polyhydroxystearic Acid, Lecithin, Phenoxyethanol, Tapioca Starch Polymethylsilsesquioxane, 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 (Birch) Bark Extract, Boswellia Serrata (Indian Frankincense) Extract, Polygonum Cuspidatum Root Extract, Caprylyl Glycol, Hexylene Glycol, Jojoba Esters, Trihydroxystearin, Alumina, Centella Asiatica (Gotu Kola) Extract, Tocopherol, Silica, Titanium Dioxide (CI 77891), Iron Oxide (CI 77492, CI 77491), Citronellol, Geraniol, Limonene, Linalool.

Package Labeling:1.5 ml

Package Labeling:100 ml

INGREDIENTS AND APPEARANCE

DR LORETTA UNIVERSAL GLOW DAILY DEFENSE SPF 40 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71501-1910
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/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SHEA BUTTER (UNII: K49155WL9Y)
ECTOIN (UNII: 7GXZ3858RY)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
TROMETHAMINE (UNII: 023C2WHX2V)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
OCTYLDODECANOL (UNII: 461N1O614Y)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
ALUMINUM OXIDE (UNII: LMI26O6933)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
TOCOPHEROL (UNII: R0ZB2556P8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71501-1910-1	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	09/01/2025
2	NDC: 71501-1910-2	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2025

Labeler - Dr. Loretta, LLC (609417121)

Registrant - Dr. Loretta, LLC (609417121)