PLAY MINERAL LIP BALM SPF-15- zinc oxide lipstick

Play Mineral Lip Balm by

Drug Labeling and Warnings

Play Mineral Lip Balm by is a Otc medication manufactured, distributed, or labeled by TUBBY TODD, Private Label Select Ltd CO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

PLAY MINERAL LIP BALM  SPF-15
zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73088-103
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: 73088-103-11	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	part352	05/21/2019

Labeler - TUBBY TODD (052545299)

Establishment
Name	Address	ID/FEI	Business Operations
Private Label Select Ltd CO		005415463	manufacture(73088-103)