SPF 15 - ZINC OXIDE LIP BALM- zinc oxide stick

SPF 15 - Zinc Oxide Lip Balm by

Drug Labeling and Warnings

SPF 15 - Zinc Oxide Lip Balm by is a Otc medication manufactured, distributed, or labeled by OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide (10.0%)

Purpose

Sunscreen

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Uses

Prevents Sunburns

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to prevent sunburn, skin cancer and/or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply liberally 15 minutes before sun exposure reapply: after 80 minutes

of swimming or sweating immediately after towel drying at least every 2 hours Sun

Protection Measures. Spending time in the sun increases your risk of skin cancer and

early skin aging To decrease the risk, regularly use a sunscreen with a broad spectrum

SPF of 15 or higher and other sun protection measures including: limit time in the sun,

especially from 10 a.m. -2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients

Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Behenyl Behenate, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Caprylic/CapricTriglyceride, Flavor, Euphorbia Cerifera (Candelilla) Wax, Persea Gratissima (Avocado) Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea Butter),Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Helianthus Annuus(Sunflower) Seed Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Melaleuca

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

SPF 15 - ZINC OXIDE LIP BALM 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63645-182
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)	205 mg  in 1 g
WHITE WAX (UNII: 7G1J5DA97F)	202 mg  in 1 g
ALMOND OIL (UNII: 66YXD4DKO9)	170 mg  in 1 g
CASTOR OIL (UNII: D5340Y2I9G)	170 mg  in 1 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63645-182-01	4 g in 1 CONTAINER; Type 0: Not a Combination Product	06/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/06/2023

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(63645-182) , LABEL(63645-182)