ABSOLUTELY NATURAL LIP BALM BROAD SPECTRUM SPF 15 SUNSCREEN- zinc oxide stick

ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Absolutely Natural. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Oil*, Flavor, Tocopherol, Soybean Oil, Aloe Extract, Canola Oil.

*Organic Ingredient

Other Information

Protect this product from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Pineapple Flavor

Pineapple Mineral Lip Balm

Made in the USA with responsibly-sourced global ingredients

Dist. by: Absolutely Natural, 640 Atlantis Rd, Melbourne, FL 32904, (800) 848-7623

Packaging

INGREDIENTS AND APPEARANCE

ABSOLUTELY NATURAL LIP BALM BROAD SPECTRUM SPF 15 SUNSCREEN 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70793-043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8 g  in 100 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		Score
Shape		Size
Flavor	PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70793-043-15	4.25 g in 1 TUBE; Type 0: Not a Combination Product	09/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/30/2024

Labeler - Absolutely Natural (166425202)