GLOW STICK BROAD SPECTRUM SPF 50- avobenzone, octisalate, octocrylene stick

Glow Stick Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Glow Stick Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Taylor James Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

PURPOSE

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.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

Warnings

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.

DOSAGE & ADMINISTRATION

Directions

• Apply generously and evenly 15 minutes before sun exposure
• Use a water-resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours.
• 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 your 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 INGREDIENT

Inactive ingredients

C12-15 Alkyl Benzoate, Calendula Officinalis Extract, Calophyllum Inophyllum Seed Oil, Caprylic/Capric Triglyceride, Dibutyl Ethylhexanol Glutamide, Dibutyl Lauroyl Glutamide, Dicaprylyl Carbonate, Diethylhexyl Syringylidenemalonate, Helianthus Annuus (Sunflower) Oil, Isododecane, Isohexadecane, Limnanthes Alba (Meadowfoam) Seed Oil, Maurita Flexuosa Fruit Oil, Octyldodecanol, Pentaclethra, Macroloba Oil, Polyester-8, Tocopherol

PRINCIPAL DISPLAY PANEL

Supergoop!

Glow Stick Sunscreen

SPF 50

1.23 oz./ 35 g

INGREDIENTS AND APPEARANCE

GLOW STICK BROAD SPECTRUM SPF 50 
avobenzone, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
TAMANU OIL (UNII: JT3LVK84A1)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISODODECANE (UNII: A8289P68Y2)
ISOHEXADECANE (UNII: 918X1OUF1E)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-157-01	35 g in 1 CYLINDER; Type 0: Not a Combination Product	12/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/20/2019

Labeler - Taylor James Ltd. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
GORDON LABORATORIES,INC		008328619	manufacture(75936-157)