FDA.reportPublic FDA data

glo SKIN BEAUTY Oil Free SPF 40

Manufacturer
Hayden Caleel LLC
Effective date
2025-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:49

Label at a glance#

Productglo SKIN BEAUTY Oil Free SPF 40
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE
Label structure9 sections

Indications and uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

• apply generously 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 a 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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Octisalate 2.5%

Zinc Oxie 7.5%

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn • if used as directed with other
sun protection measures (see Directions), decreases the
risk of skin cancer and early skin aging caused by the sun

Warnings

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 use and ask a docor if rash occurs

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

Directions

DOSAGE & ADMINISTRATION SECTION

• apply generously 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 a 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Isopropyl Palmitate, Ethylhexyl Stearate, Ethylhexyl Isononanoate, Cyclopentasiloxane, Cetearyl Glucoside, Dimethicone, Phenoxyethanol, Glycereth-26, Oleth-3 Phosphate, Allantoin, Triethoxycaprylylsilane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Panthenol, Butylene Glycol, PEG-7 Trimethylolpropane Coconut Ether, Sodium Hyaluronate, Tocopheryl Acetate, Ascorbyl Palmitate, Iodopropynyl Butylcarbamate

Other Information

SPL UNCLASSIFIED SECTION

• protect the product in this container from excessive
heat and direct sun

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Purpose

OTC - PURPOSE SECTION

Sunscreen

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60541-10060541-100

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60541-1000-52025-01-05C16284748780-19d75b9d0-9b77-f424-e053-dadaa90a57ceDRUG FACTS
60541-1000-52020-01-31C16284748780-19d75b9d0-9b77-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60541-1000-5glo SKIN BEAUTY Oil Free SPF 401 in 1 CARTONLOTION12
60541-1000-5glo SKIN BEAUTY Oil Free SPF 4050 g in 1 TUBELOTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60541-1000GLO SKIN BEAUTY OIL FREE SPF 40 LOTION [HAYDEN CALEEL LLC]2Current NDC, Legacy NDC, 2 package rows20250107_6b27a508-8669-418f-bcb2-61a35b79a3a8.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60541-100060541-1000-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
ETHYLHEXYL ISONONANOATEI6KB4GE3K4IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERETH-26NNE56F2N14IACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
ALLANTOIN344S277G0ZIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PANTHENOLWV9CM0O67ZIACT
ASCORBYL PALMITATEQN83US2B0NIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
glo SKIN BEAUTY Oil Free SPF 40GLO SKIN BEAUTY OIL FREE SPF 40Hayden Caleel LLC6b27a508-8669-418f-bcb2-61a35b79a3a82025-01-05WarningsExact identifier
ndc (package): 60541-1000-5
ndc (product): 60541-1000
ndc11 (package): 60541100005
spl id: 2af80b5d-d1d0-87cf-e063-6294a90a5c6a
spl set id: 6b27a508-8669-418f-bcb2-61a35b79a3a8

Reported adverse events (FAERS/openFDA)#

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