LIP SHIELD- titanium dioxide, zinc oxide stick

Lip Shield by

Drug Labeling and Warnings

Lip Shield by is a Otc medication manufactured, distributed, or labeled by Skin Apeel, Inc., Fragrance Manufacturing Inc., Custom Analytics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Titanium Dioxide: 4%

Zinc Oxide: 5.5%

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 aging caused by the sun.

Warnings:

For external use only. Do not use on broken or damaged 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.

Warnings:

Keep out of reach of children

Directions:

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: 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 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Asorbic Acid, Ascorbyl Palmitate, C12-15Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Other Information:

reef friendly

cruelty free

non-comedogenic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIP SHIELD 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83628-212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	55 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
CI 77492 (UNII: EX438O2MRT)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
STEARIC ACID (UNII: 4ELV7Z65AP)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CI 77491 (UNII: 1K09F3G675)
HEXYLDECANOL (UNII: 151Z7P1317)
TOCOPHEROL (UNII: R0ZB2556P8)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
PEG-8 (UNII: B697894SGQ)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
CI 77499 (UNII: XM0M87F357)
ALUMINA (UNII: LMI26O6933)
CITRIC ACID (UNII: 2968PHW8QP)

Product Characteristics
Color		Score
Shape		Size
Flavor	LIME, KIWI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83628-212-45	1 in 1 CARTON	01/02/2025
1		4.5 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/02/2025

Labeler - Skin Apeel, Inc. (840716328)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(83628-212)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(83628-212)