MINERAL LIP BALM PINEAPPLE- zinc oxide stick

Mineral Lip Balm by

Drug Labeling and Warnings

Mineral Lip Balm by is a Otc medication manufactured, distributed, or labeled by Synchronicity Spa, Inc. DBA Suntegrity. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc Oxide 8.0%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

• 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.

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 of age: Ask a doctor

Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10a.m. – 2p.m.
• wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Sunflower Oil, Beeswax, Olive Oil1, Flavor, Tocopherol, Soybean Oil, Aloe Extract, Canola Oil.

1 Organic Ingredient

Other Information

Protect this product from excessive heat and direct sun.

STORAGE AND HANDLING

Dist. By: Synchronicity Spa, Inc. DBA: Suntegrity Las Vegas, NV USA, 89128

PRINCIPAL DISPLAY PANEL - 4.25 g Tube Label

sun
tegrity®

MINERAL
LIP BALM

PINEAPPLE

BROAD SPECTRUM SPF 15

SPF 15

NON-NANO ZINC OXIDE

Reef-Friendly
Cruelty-Free

INGREDIENTS AND APPEARANCE

MINERAL LIP BALM   PINEAPPLE
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69949-559
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.34 g  in 4.25 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
WHITE WAX (UNII: 7G1J5DA97F)
OLIVE OIL (UNII: 6UYK2W1W1E)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CANOLA OIL (UNII: 331KBJ17RK)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69949-559-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product	07/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	07/15/2025

Labeler - Synchronicity Spa, Inc. DBA Suntegrity (079164130)