FDA.reportPublic FDA data

Lip Shield

Manufacturer
Skin Apeel, Inc. | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:11

Label at a glance#

ProductLip Shield
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and 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.

Dosage and administration

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 inclu...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide: 4%

Zinc Oxide: 5.5%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

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:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

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:

OTHER SAFETY INFORMATION

reef friendly

cruelty free

non-comedogenic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83628-212-45Lip Shield1 in 1 CARTONSTICK12
83628-212-45Lip Shield4.5 g in 1 CYLINDERSTICK4.52

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83628-21283628-212-45
58892-212

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETEARYL ISONONANOATEP5O01U99NIIACT
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTERR6G12EY23XIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
CI 77492EX438O2MRTIACT
PEG/PPG-15/15 DIMETHICONE184IZ28A2GIACT
CERESINQ1LS2UJO3AIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
ASCORBYL PALMITATEQN83US2B0NIACT
ETHYLHEXYL PALMITATE2865993309IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
STEARIC ACID4ELV7Z65APIACT
ZINGIBER OFFICINALE (GINGER) ROOT OILSAS9Z1SVUKIACT
ZINC OXIDESOI2LOH54ZACTIB
LECITHIN, SOYBEAN1DI56QDM62IACT
CI 774911K09F3G675IACT
HEXYLDECANOL151Z7P1317IACT
TOCOPHEROLR0ZB2556P8IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
HEXYLDECYL LAURATE0V595C1P6MIACT
CETYL DIMETHYLBUTYL ETHER7LAB1GXG9GIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
PEG-8B697894SGQIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX42DG15CHXVIACT
CI 77499XM0M87F357IACT
ALUMINALMI26O6933IACT
CITRIC ACID2968PHW8QPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lip ShieldTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c545e55-3f55-842b-e063-6394a90ae48e2025-12-08WarningsExact identifier
ndc (package): 83628-212-45
ndc (product): 83628-212
ndc11 (package): 83628021245
spl id: 45766016-6bee-e311-e063-6394a90a9c65
spl set id: 3c545e55-3f55-842b-e063-6394a90ae48e
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1d611494-648b-6e5f-e063-6294a90a45002024-07-16WarningsExact identifier
ndc (product): 58892-212

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.