GLOW STICK BROAD SPECTRUM SPF 50- avobenzone, homosalate, octinoxate, octisalate 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 Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone3% Sunscreens

Homosalate 10%

Octinoxate 7.5%

Octisalate 5%

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
• 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: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

Supergoop! Glow Stick Sunscreen SPF 50

Broad Spectrum Sunscreen SPF 50

1.23 oz./ 35 g

INGREDIENTS AND APPEARANCE

GLOW STICK BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octinoxate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-144
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEADOWFOAM SEED OIL FATTY ACIDS (UNII: MK2D1PBV6N)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOHEXADECANE (UNII: 918X1OUF1E)
TAMANU OIL (UNII: JT3LVK84A1)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
PENTACLETHRA MACROLOBA SEED OIL (UNII: OM0BAV5397)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-144-01	35 g in 1 CARTON; Type 0: Not a Combination Product	01/03/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/03/2018

Labeler - Taylor James Ltd. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
GORDON LABORATORIES,INC		008328619	manufacture(75936-144)