FDA.reportPublic FDA data

Dr Loretta Universal Glow Daily Defense SPF 40

Manufacturer
Dr. Loretta, LLC
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:36:38

Label at a glance#

ProductDr Loretta Universal Glow Daily Defense SPF 40
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 17%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

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, 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 LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

Package Labeling:100 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: ​10 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label CartonLabel CartonLabel BottleLabel Bottle

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130185854000878GTIN-13: 0185854000878
EAN-13: 0185854000878
GTIN-12: 185854000878
UPC-A: 185854000878
GTIN storage (14 digits): 00185854000878		Label0.jpg
BarcodeEAN-130850061042415GTIN-13: 0850061042415
EAN-13: 0850061042415
GTIN-12: 850061042415
UPC-A: 850061042415
GTIN storage (14 digits): 00850061042415		Label2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71501-1910-1Dr Loretta Universal Glow Daily Defense SPF 401.5 mL in 1 PACKETCREAM1.52
71501-1910-2Dr Loretta Universal Glow Daily Defense SPF 40100 mL in 1 BOTTLE, PUMPCREAM1002
71501-1910-3Dr Loretta Universal Glow Daily Defense SPF 401 in 1 BOXCREAM12
71501-1910-3Dr Loretta Universal Glow Daily Defense SPF 4010 mL in 1 BOTTLE, PUMPCREAM102

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71501-191071501-1910-1, 71501-1910-2, 71501-1910-3

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISODODECANEA8289P68Y2IACT
PROPANEDIOL5965N8W85TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATEX2PZH4Y6HTIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
ETHYLHEXYL PALMITATE2865993309IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
POLYGLYCERYL-10 DIOLEATE598RES7AXXIACT
PROPYLENE CARBONATE8D08K3S51EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SHEA BUTTERK49155WL9YIACT
ECTOIN7GXZ3858RYIACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-10 LAURATEMPJ2Q8WI8GIACT
TROMETHAMINE023C2WHX2VIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
OCTYLDODECANOL461N1O614YIACT
LAVENDER OILZBP1YXW0H8IACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DIMETHYLMETHOXY CHROMANOLXBH432G01FIACT
SODIUM BENZOATEOJ245FE5EUIACT
BETULA PUBESCENS BARK3R504894L9IACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
REYNOUTRIA JAPONICA ROOT7TRV45YZF7IACT
CAPRYLYL GLYCOL00YIU5438UIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
TRIHYDROXYSTEARIN06YD7896S3IACT
ALUMINUM OXIDELMI26O6933IACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
TOCOPHEROLR0ZB2556P8IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

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
Dr Loretta Universal Glow Daily Defense SPF 40ZINC OXIDEDr. Loretta, LLC1208d0f8-bb12-4574-b70e-3a76b11a64c72026-01-07WarningsExact identifier
ndc (package): 71501-1910-2
ndc (package): 71501-1910-3
ndc (package): 71501-1910-1
ndc (product): 71501-1910
ndc11 (package): 71501191002
ndc11 (package): 71501191001
ndc11 (package): 71501191003
spl id: 47cc5bc2-c2d5-d1a4-e063-6294a90a5dc8
spl set id: 1208d0f8-bb12-4574-b70e-3a76b11a64c7

Reported adverse events (FAERS/openFDA)#

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