Drug Facts

Active Ingredients

Zinc Oxide 9.4%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

KEEP OUT OF REACH OF CHILDREN

Directions

Apply generously 15 minutes before sun exposure.
Reapply every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
Children undre 6 months of age: Ask a doctor
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: Sun Protection Measures.
limit time in the sun, especially from 10 a.m.-2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Diisostearyl Dimer Dilinoleate, Synthetic Beeswax, Euphorbia Cerifera (Candelilla) Wax, Triisostearin, Helianthus Annuus (Sunflower) Seed Oil, Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Ozokerite, Ricinus Communis (Castor) Seed Oil, Jojoba Esters, Butyrospermum Parkii (Shea) Butter, Sucrose Tetrastearate Triacetate, Caprylic/Capric Triglyceride, Tocopherol, Tocopheryl Acetate, Caprylyl Glycol, 1,2-Hexanediol, Triethoxycaprylylsilane, Ethyl Ferulate

Package Labeling:

Outer Package Inner Package Box

CUROLOGY THE LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82575-034
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	94 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIISOSTEARYL DIMER DILINOLEATE (UNII: 04P17590AP)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
CANDELILLA WAX (UNII: WL0328HX19)
TRIISOSTEARIN (UNII: 71503RH8KG)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
CASTOR OIL (UNII: D5340Y2I9G)
SHEA BUTTER (UNII: K49155WL9Y)
SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYL FERULATE (UNII: 5B8915UELW)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82575-034-01	1 in 1 CARTON	07/16/2022
1		4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	07/16/2022

Labeler - Curology Inc. (104103284)

Curology The Lip Balm Broad Spectrum SPF 30 Sunscreen