GLOW OIL BROAD SPECTRUM SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene oil

Glow Oil Broad Spectrum Sunscreen SPF 50 by

Drug Labeling and Warnings

Glow Oil Broad Spectrum Sunscreen 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

Avobenzone 3% Sunscreen

Homosalate 10% 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

Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
For external use only

DOSAGE & ADMINISTRATION

Directions

• Apply generously and evenly 15 minutes before sun exposure
• Reapply
• at least every 2 hours.
• after 80 minutes 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 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

Caprylic/Capric Triglyceride, Alcohol, Octyldodecanol, C12-15 Alkyl Benzoate, Polyester-8, Polyamide-3, Lauryl Lactate, Isodecyl Neopentanoate, Diisopropyl Sebacate, Diethylhexylsyringylidenemalonate, Tocopherol, Glycine Soja (Soybean)Oil, Vitis Vinifera (grape) Seed Oil, Raphanus Sativus (Radish) Seed Oil, Limnanthes Alba(Meadowfoam) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (coconut) Oil, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Pentaerythrityl Tetra-di-t-butyl hydroxyhydrocinnamate. Alaria Esculanta Extract, t-Butyl Alcohol, Cucumis Sativus(cucumber) Fruit Extract, Denatonium Benzoate, Citric Acid

PRINCIPAL DISPLAY PANEL

Supergoop!

Glow Oil SPF 50

Broad Spectrum Sunscreen SPF 50

Water Resistant (80 minutes) 5 fl. oz./ 148 ml

INGREDIENTS AND APPEARANCE

GLOW OIL BROAD SPECTRUM SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-152
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GRAPE SEED OIL (UNII: 930MLC8XGG)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
OCTYLDODECANOL (UNII: 461N1O614Y)
LAURYL LACTATE (UNII: G5SU0BFK7O)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALCOHOL (UNII: 3K9958V90M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ARGAN OIL (UNII: 4V59G5UW9X)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
CUCUMBER (UNII: YY7C30VXJT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-152-01	148 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2019
2	NDC: 75936-152-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/12/2019

Labeler - Taylor James, Ltd. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc.		620899877	manufacture(75936-152)