LIP BALM- oxybenzone octinoxate ointment

Lip Balm by

Drug Labeling and Warnings

Lip Balm by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients
Oxybenzone 3.0%
Octinoxate 7.5%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses Helps prevent sunburn

WARNINGS

Warnings
Skin Cancer/Skin Aging Alert: Spending me in the sun increases your
  risk of skin cancer and early skin aging. This product has been shown
  only to help prevent sunburn, not skin cancer or early skin aging.
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. Rinse with water to remove.
Keep out of reach of children. If swallowed, get medical help or contact
a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
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: Ask a doctor 

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

Inactive Ingredients: Helianthus Annuus (Sunflower) Seed Oil, Glycine Soja (Soybean)
Oil, Beeswax, Flavor, Euphorbia Cerifera (Candelilla) Wax, Cannabis Sativa Seed Oil, Limnathes
Alba (Meadowfoam) Seed Oil, Mangifera Indica (Mango) Seed Butter, Rosmarinus Officinalis (Rosemary)
Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis Leaf Extract, Mineral Oil,
Tocopherol.

QUESTIONS

Questions or Comments? www.pamelameganhines.com

Package Labeling

Perfect LIPS

BY PERFECT PEACE

SPF 15 LIP MOISTURIZER      Net Wt. : 0.15 oz / 4.2 g

Manufactured/Distributed by Perfect Peace LLC

3900 W Brown Deer Rd Suite 273 Brown Deer WI 53209

SAFETY SEAL

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INGREDIENTS AND APPEARANCE

LIP BALM 
oxybenzone octinoxate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL MONOGLYCERIDES (UNII: ZVW8EIZ3IE)
SOYBEAN OIL (UNII: 241ATL177A)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
ROSEMARY (UNII: IJ67X351P9)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MINERAL OIL (UNII: T5L8T28FGP)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-151-50	4.2 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2020

Labeler - Bentley Laboratories, LLC (068351753)

Registrant - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(54111-151)