FDA.reportPublic FDA data

Glow Stick

Manufacturer
Skin Apeel, Inc. | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:11

Label at a glance#

ProductGlow Stick
Active ingredientTITANIUM DIOXIDE, 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 liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. 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 inclu...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4%

Zinc Oxide 5.5%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

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 broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childen

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. 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.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Ethylene Brassylate, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Wax, Hexyldecanol, Hexyldecyl Laurate, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Propylene Glycol Dicaprylate/Dicaprate, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Other Information:

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130383628219307GTIN-13: 0383628219307
EAN-13: 0383628219307
GTIN-12: 383628219307
UPC-A: 383628219307
GTIN storage (14 digits): 00383628219307		APEEL 219.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83628-219-30Glow Stick30 g in 1 CYLINDERSTICK302

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83628-21983628-219-30
58892-219

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
CETYL DIMETHYLBUTYL ETHER7LAB1GXG9GIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CITRIC ACID2968PHW8QPIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX42DG15CHXVIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
HEXYLDECYL LAURATE0V595C1P6MIACT
CERESINQ1LS2UJO3AIACT
PEG-8B697894SGQIACT
ALUMINALMI26O6933IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
STEARIC ACID4ELV7Z65APIACT
ETHYLHEXYL PALMITATE2865993309IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ZINC OXIDESOI2LOH54ZACTIB
ALUMINUM STEARATEU6XF9NP8HMIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATEO4446S9CRAIACT
ZINGIBER OFFICINALE (GINGER) ROOT OILSAS9Z1SVUKIACT
TOCOPHEROLR0ZB2556P8IACT
HEXYLDECANOL151Z7P1317IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ASCORBYL PALMITATEQN83US2B0NIACT
PEG/PPG-15/15 DIMETHICONE184IZ28A2GIACT
ETHYLENE BRASSYLATE9A87HC7RODIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glow StickTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c54b857-c017-a953-e063-6394a90a38df2025-12-08WarningsExact identifier
ndc (package): 83628-219-30
ndc (product): 83628-219
ndc11 (package): 83628021930
spl id: 45765ae8-c1e1-e5bd-e063-6394a90ac5b2
spl set id: 3c54b857-c017-a953-e063-6394a90a38df
Proceuticals Private Label by TiZO non-tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd20e86260-d641-c9ac-e063-6394a90ac07d2024-08-30WarningsExact identifier
ndc (product): 58892-219

Reported adverse events (FAERS/openFDA)#

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