Image MD Restoring Lip Enhancer SPF15

Manufacturer
Swiss-American CDMO, LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:29

Label at a glance#

ProductImage MD Restoring Lip Enhancer SPF15
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure10 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply 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 this 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 fro...

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

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 doctor if rash occurs. If swallowed get medical help or contact a Poison Control Center right away.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone   3.0%   Sunscreen

Homosalate   10.0%   Sunscreen

Octisalate   5.0%   Sunscreen

Octocrylene   4.0%   Sunscreen

Indications & Usage

OTC - PURPOSE SECTION

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

Keep out of reach of children

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 sunscreen if swimming or sweating. Reapply 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 this 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 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Directions

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply 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 this 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 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydrogenated polyisobutene, ethylene/propylene/styrene copolymer, Pentaerythrityl Tetraisostearate, ethylhexyl palmitate, PPG-12/SMDI Copolymer, butylene/ethylene/styrene copolymer, flavor, limonene, tribehenin, phenyl trimethicone, sorbitan isostearate, silican dimethyl silylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, butylene glycol, pentylene glycol, lactic acid, linalool, sodium chondrotin sulfate, citral, atelocollagen, palmitoyl tripeptide-1, Avacodo (Persea gratissima) Oil, Diisopropyl Dimer Dilinoleate, Tocopheryl Acetate, Tocopherol, Oryzanol, Ubiquinone.

Questions

OTC - QUESTIONS SECTION

Questions call 800-796-7546

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image Lip Enhancer UCImage Lip Enhancer UC

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60232-3537-0Image MD Restoring Lip Enhancer SPF1515 g in 1 TUBECREAM152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60232-3537IMAGE MD RESTORING LIP ENHANCER SPF15 (SUNSCREEN) CREAM [SWISS-AMERICAN CDMO, LLC]2Current NDC, Legacy NDC, 1 package rows20231108_e296579e-ba30-4a29-afe0-bb51f863369c.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60232-353760232-3537-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Image MD Restoring Lip Enhancer SPF15SUNSCREENSwiss-American CDMO, LLCe296579e-ba30-4a29-afe0-bb51f863369c2023-11-06WarningsExact identifier
ndc (package): 60232-3537-0
ndc (product): 60232-3537
ndc11 (package): 60232353700
spl id: 88ede635-3a2c-45af-9e56-854ac5c125d9
spl set id: e296579e-ba30-4a29-afe0-bb51f863369c

Reported adverse events (FAERS/openFDA)#

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