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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)
Available from:
Bentley Laborotories, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Sunscreen Uses Helps prevent sunburn
Authorization status:
OTC monograph final
Authorization number:
54111-141-50

GOSLINGS CHOPSAVER BROAD SPECTRUM SPF LIP BALM- avobenzone, octinoxate,

octisalate, octocrylene stick

Bentley Laborotories, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ChopSaver

Lip Care

Drug Facts

Active Ingredients

Avobenzone (2%)

Octinoxate (6.5%)

Octisalate (5%)

Octocrylene (1.5%)

Purpos e

Sunscreen

Us es

Helps prevent sunburn

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.

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 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 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

®

GOSLINGS CHOPSAVER BROAD SPECTRUM SPF LIP BALM

avobenzone, octinoxate, octisalate, octocrylene stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:54111-141

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

2 g in 10 0 g

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

6 .5 g in 10 0 g

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

5 g in 10 0 g

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

1.5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

CASTO R O IL (UNII: D5340 Y2I9 G)

CANDELILLA WAX (UNII: WL0 328 HX19 )

YELLO W WAX (UNII: 2ZA36 H0 S2V)

SHEA BUTTER (UNII: K49 155WL9 Y)

MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9 M35X2)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

AVO CADO O IL (UNII: 6 VNO72PFC1)

APRICO T KERNEL O IL (UNII: 54JB35T0 6 A)

GRAPE SEED O IL (UNII: 9 30 MLC8 XGG)

ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ)

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

LEMO N O IL (UNII: I9 GRO8 24LL)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

GRAPEFRUIT O IL (UNII: YR377U58 W9 )

O RANGE O IL (UNII: AKN3KSD11B)

LIME O IL (UNII: UZH29 XGA8 G)

GINGER O IL (UNII: SAS9 Z1SVUK)

RUBUS IDAEUS LEAF (UNII: 8 O2V33JG6 4)

CO MFREY LEAF (UNII: DG4F8 T8 39 X)

SALIX ALBA BARK (UNII: 20 5MXS71H7)

PEA PRO TEIN (UNII: 7Q50 F46 59 5)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:54111-141-50

4.25 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /31/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 8 /31/20 19

Labeler -

Bentley Laborotories, LLC (068351753)

Bentley Laborotories, LLC

Registrant -

Bentley Laborotories, LLC (068351753)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bentley Labo ro to ries, LLC

0 6 8 351753

ma nufa c ture (54111-141)

Revised: 8/2019

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