LIP SHIELD- zinc oxide lipstick
HydroPeptide LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lip Shield

Drug Facts

Active Ingredients

Zinc Oxide (10.5%)

Purpose

Sunscreen

Uses

Helps prevent sunburn. If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin again caused by the sun.

Warnings

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.

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

Directions

- Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating.

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 10 a.m. -2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor

Inactive Ingredients

Butyrospermum Parkii (Shea) Butter, Calophyllum Inophyllum (Tamanu) Seed Oil, Caprylic/Capric Triglyceride, Cera Alba (Beeswax), Cocos Nucifera (Coconut) Oil, Helianthus Annus (Sunflower) Seed Oil, Natural Flavors, Polyhydroxystearic Acid, Rubus Idaeus (Red Raspberry) Seed Oil, Simmondsia Chinensis (Jojoba) Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol

Other Information

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

Questions or comments?

Call 1.800.932.9873

Package Labeling:

Label4

LIP SHIELD
zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60934-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	105 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SHEA BUTTER (UNII: K49155WL9Y)
TAMANU OIL (UNII: JT3LVK84A1)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WHITE WAX (UNII: 7G1J5DA97F)
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
RASPBERRY SEED OIL (UNII: 9S8867952A)
JOJOBA OIL (UNII: 724GKU717M)
COCOA BUTTER (UNII: 512OYT1CRR)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60934-006-01	1 in 1 BOX	06/01/2018
1		7.4 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/01/2018	12/31/2021

Labeler - HydroPeptide LLC (006297465)

Revised: 11/2022

Document Id: eca68493-ccf5-32ad-e053-2995a90acc7c

Set id: 8793876d-352a-4c8e-bdbc-9f3f9215233b

Version: 4

Effective Time: 20221104

HydroPeptide LLC