Tubby Todd (as PLD) - Mineral Lip Balm SPF-15 (73088-105)

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]

MINERAL LIP BALM SPF-15- zinc oxide lipstick 
TUBBY TODD

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.

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Tubby Todd (as PLD) - Mineral Lip Balm SPF-15 (73088-105)

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.

DIRECTIONS

Apply liberally and as needed.

OTHER INFORMATION

Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENT

Helianthus Annuus (Sunflower) Seed Oil*, Beeswax*, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil*, Natural Flavor, Polyhydrostearic Acid, Butyrospermum Parkii (Shea) Butter*, Tocopherol, Simmondsia Chinensis (Jojoba) Seed Oil*, Calophyllum Inophyllum (Tamanu) Seed Oil*

*Certified organic ingredient(s)

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)
CASTOR OIL (UNII: D5340Y2I9G)
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 final	M020	05/21/2019

Labeler - TUBBY TODD (052545299)

Revised: 7/2023

Document Id: 016c62bb-5ea2-c5eb-e063-6294a90a3add

34390-5

Set id: 4d938672-5302-4e47-a582-c3e6467008cb

Version: 6

Effective Time: 20230726

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