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NDC 73088-0105-11 Mineral Lip Balm 10.5 g/100g Details

Mineral Lip Balm 10.5 g/100g

Mineral Lip Balm is a TOPICAL LIPSTICK in the HUMAN OTC DRUG category. It is labeled and distributed by TUBBY TODD. The primary component is ZINC OXIDE.

Product Information

NDC	73088-0105
Product ID	73088-105_da338def-4927-fba2-e053-2a95a90a28a6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Mineral Lip Balm
Proprietary Name Suffix	SPF-15
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LIPSTICK
Route	TOPICAL
Active Ingredient Strength	10.5
Active Ingredient Units	g/100g
Substance Name	ZINC OXIDE
Labeler Name	TUBBY TODD
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 73088-0105-11 (73088010511)

Pricing Information	N/A
NDC Package Code	73088-105-11
Billing NDC	73088010511
Package	4.2 g in 1 TUBE (73088-105-11)
Marketing Start Date	2019-05-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4d938672-5302-4e47-a582-c3e6467008cb Details

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

SPL UNCLASSIFIED SECTION

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)

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	05/21/2019

Labeler - TUBBY TODD (052545299)

Revised: 3/2022

Document Id: da338def-4927-fba2-e053-2a95a90a28a6

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

Version: 5

Effective Time: 20220314