FDA.reportPublic FDA data

Universal Glow Daily Defense SPF 40

Manufacturer
Dr. Loretta, LLC
Effective date
2023-05-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:53

Label at a glance#

ProductUniversal Glow Daily Defense SPF 40
Active ingredientSALICYLIC ACID
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 17%

OTC - PURPOSE SECTION

Sunscreen

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Helps prevent suburn

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle display PanelPrinciple display Panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71501-1903-12025-01-30C16284748780-12cef2736-864d-d83d-e063-dadaa90ab31fUniversal Glow Daily Defense SPF 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71501-1903-1Universal Glow Daily Defense SPF 4050 mL in 1 TUBECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71501-1903UNIVERSAL GLOW DAILY DEFENSE SPF 40 (ZINC OXIDE) CREAM [DR. LORETTA, LLC]11 package rows20230505_fae21e0a-5e41-bffb-e053-6294a90afb9d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71501-190371501-1903-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROMETHAMINE023C2WHX2VIACT
LAVENDER OILZBP1YXW0H8IACT
ALUMINUM OXIDELMI26O6933IACT
ISODODECANEA8289P68Y2IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIMETHICONE92RU3N3Y1OIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
ETHYLHEXYL PALMITATE2865993309IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
POLYGLYCERYL-10 DIOLEATE598RES7AXXIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SHEA BUTTERK49155WL9YIACT
ECTOINE7GXZ3858RYIACT
GLYCERINPDC6A3C0OXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHYLMETHOXY CHROMANOLXBH432G01FIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
FERRIC OXIDE RED1K09F3G675IACT
PROPANEDIOL5965N8W85TIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
PROPYLENE CARBONATE8D08K3S51EIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
OCTYLDODECANOL461N1O614YIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATEX2PZH4Y6HTIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
POLYGLYCERYL-10 LAURATEMPJ2Q8WI8GIACT
POLYGONUM CUSPIDATUM ROOT7TRV45YZF7IACT
TRIHYDROXYSTEARIN06YD7896S3IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
STARCH, TAPIOCA24SC3U704IIACT
BETULA PUBESCENS BARK3R504894L9IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fae21e0a-5e42-bffb-e053-6294a90afb9dfae21e0a-5e41-bffb-e053-6294a90afb9d2023-05-04WarningsExact identifier
spl id: fae21e0a-5e42-bffb-e053-6294a90afb9d
spl set id: fae21e0a-5e41-bffb-e053-6294a90afb9d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.