SPF 30 - ZINC OXIDE LIP BALM- zinc oxide stick

SPF 30 - Zinc Oxide Lip Balm by

Drug Labeling and Warnings

SPF 30 - 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 (15.0%)

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

Behenyl Behenate, Butyrospermum Parkii (Shea Butter), Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Wax, Oryza Sativa (Rice) Bran Extract, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ricinus Communis (Castor) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E).

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

SPF 30 - ZINC OXIDE LIP BALM 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63645-184
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)	202 mg  in 1 g
WHITE WAX (UNII: 7G1J5DA97F)	182 mg  in 1 g
CASTOR OIL (UNII: D5340Y2I9G)	162 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: 63645-184-01	4 g in 1 CONTAINER; Type 0: Not a Combination Product	02/03/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	352	02/03/2025

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	manufacture(63645-184) , label(63645-184) , analysis(63645-184)