GOSLINGS CHOPSAVER BROAD SPECTRUM SPF LIP BALM- avobenzone, octinoxate, octisalate, octocrylene stick

GOSLINGS CHOPSAVER BROAD SPECTRUM SPF LIP BALM by

Drug Labeling and Warnings

GOSLINGS CHOPSAVER BROAD SPECTRUM SPF LIP BALM by is a Otc medication manufactured, distributed, or labeled by Bentley Laborotories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients

Avobenzone (2%)

Octinoxate (6.5%)

Octisalate (5%)

Octocrylene (1.5%)

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses

Helps prevent sunburn

WARNINGS

Warnings: For external use only.

• Do not use on damaged or broken skin.
• Stop use and ask a doctor if rash occurs.
• When using this product keep out of eyes.
• Keep out of reach of children.  If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

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 protection measures including:
                  limit time in the sun, especially from 10a.m. - 2p.m.
                  wear long sleeved shirts, pants, hat, and sunglasses.

Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours
Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients: Castor Oil*, Candolili Wax*, Beeswax*, Shea

Butter*, Mango Butter, Aloe Vera, Carhauba Wax*, Avacado Oil*, Apricot Kernel

Oil*, Grapseed Oil*, Amica, Calendula*, Comfrey, Raspberry Leaf*, White

Willow, Vitamin E, Citrus Essential Oils, Ginger Essential Oil*, Pea Isolate,

*Certified Organic Ingredient Contains No Animal Fats - Gluten Free

OTHER SAFETY INFORMATION

Other Information: Protect this product from excessive heat and direct sun.

Package Labeling

SPF 15 BROAD SPECTRUM

Gosling's Original

ChopSaver®

Lip Care

BROAD SPECTRUM SPF 15 Sunscreen

ChopSaver Lip Balm

Made in the USA

Net Wt. .15oz.

1 82740 0001 1

Dist. by: Good For The Goose Products LLC Indianapolis IN 46220

SAFETY SEAL

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INGREDIENTS AND APPEARANCE

GOSLINGS CHOPSAVER BROAD SPECTRUM SPF LIP BALM 
avobenzone, octinoxate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARNAUBA WAX (UNII: R12CBM0EIZ)
AVOCADO OIL (UNII: 6VNO72PFC1)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
GRAPE SEED OIL (UNII: 930MLC8XGG)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
LEMON OIL (UNII: I9GRO824LL)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GRAPEFRUIT OIL (UNII: YR377U58W9)
ORANGE OIL (UNII: AKN3KSD11B)
LIME OIL (UNII: UZH29XGA8G)
GINGER OIL (UNII: SAS9Z1SVUK)
RUBUS IDAEUS LEAF (UNII: 8O2V33JG64)
COMFREY LEAF (UNII: DG4F8T839X)
SALIX ALBA BARK (UNII: 205MXS71H7)
PEA PROTEIN (UNII: 7Q50F46595)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-141-50	4.25 g in 1 TUBE; Type 0: Not a Combination Product	08/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/31/2019

Labeler - Bentley Laborotories, LLC (068351753)

Registrant - Bentley Laborotories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laborotories, LLC		068351753	manufacture(54111-141)