GLOW STICK- titanium dioxide, zinc oxide stick

Glow Stick by

Drug Labeling and Warnings

Glow Stick by is a Otc medication manufactured, distributed, or labeled by Skin Apeel, Inc., Custom Analytics LLC, Fragrance Manufacturing Inc., Fallien Cosmeceuticals Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Titanium Dioxide 4%

Zinc Oxide 5.5%

Purpose:

Sunscreen

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.

Warnings:

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:

Keep out of reach of childen

Directions:

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:

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:

• Protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GLOW STICK 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83628-219(NDC:58892-219)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	55 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CITRIC ACID (UNII: 2968PHW8QP)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
CERESIN (UNII: Q1LS2UJO3A)
PEG-8 (UNII: B697894SGQ)
ALUMINA (UNII: LMI26O6933)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
TOCOPHEROL (UNII: R0ZB2556P8)
HEXYLDECANOL (UNII: 151Z7P1317)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83628-219-30	30 g in 1 CYLINDER; Type 0: Not a Combination Product	07/28/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/28/2025

Labeler - Skin Apeel, Inc. (840716328)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(83628-219)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(83628-219)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(83628-219)