MINERAL LIP BALM SPF-15- zinc oxide lipstick

Mineral Lip Balm by

Drug Labeling and Warnings

Mineral Lip Balm by is a Otc medication manufactured, distributed, or labeled by TUBBY TODD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Zinc Oxide 10.5%

Purpose

Sunscreen

Uses

Helps protect against sunburn and chapped lips.

Warnings

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

If amount greater than normal use is swallowed get medical attention or call Poison Control Center immediately.

Stop use and ask a doctor

if rash occurs

Stop use and ask a doctor

if rash occurs

Directions

Apply liberally and as needed.

Other information

Protect this product from excessive heat and direct sun.

Inactive ingredients

Helianthus Annuus (Sunflower) Seed Oil*, Beeswax*, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil*, Natural Flavor*, Polyhydroxystearic Acid, Butyrospermum Parkii (Shea) Butter*, Rubus Idaeus (Raspberry) Seed Oil, Theobroma Cacao (Cocoa) Butter*, Tocopherol, Simmondsia Chinensis (Jojoba) Seed Oil*, Calophyllum Inophyllum (Tamanu) Seed Oil*
*Certified organic ingredient(s)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL LIP BALM  SPF-15
zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73088-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SHEA BUTTER (UNII: K49155WL9Y)
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
TOCOPHEROL (UNII: R0ZB2556P8)
COCOA BUTTER (UNII: 512OYT1CRR)
JOJOBA OIL (UNII: 724GKU717M)
TAMANU OIL (UNII: JT3LVK84A1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73088-105-11	4.2 g in 1 TUBE; Type 0: Not a Combination Product	05/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/21/2019

Labeler - TUBBY TODD (052545299)