FDA.reportPublic FDA data

Lip Renewal SPF 50

Manufacturer
June Jacobs Labs, LLC
Effective date
2024-05-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:33

Label at a glance#

ProductLip Renewal SPF 50
Active ingredientOCTINOXATE, AVOBENZONE, HOMOSALATE, OCTISALATE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Avobenzone...........................3.0%

Homosalate...........................10.0%

Octinoxate.............................7.5%

Octisalate..............................5.0%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For External use only

OTC - DO NOT USE SECTION

Do not use on

  • damaged or broken skin

OTC - WHEN USING SECTION

When using this product

  • Keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If product is swallowed, get madical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply liberally and evenly every 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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 as sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun especially from 10am -2 pm.
  • wear long sleeve shirt, pants hats and sunglasses

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Microcrystalline Wax, Diisostearyl Malate, Glyceryl Diisostearate, Simmondsia Chinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea) Butter, Dimethicone, Glycerin, Vitis Vinifera (Grape) Seed Oil, Flavor (Aroma), Triisostearin, Tocopherol, Squalane, Lycium Barbarum Fruit Extract, Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract, Allantoin, Water/ Aqua, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Hyaluronic Acid, Phenoxyethanol, Limonene, Citral

OTHER SAFETY INFORMATION

Other Information

  • Protect this product from excessive heat and direct sun.

OTC - QUESTIONS SECTION

Questions or comments?

Call toll free 1-866-JUNEJACOBS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lip Renewal TbLip Renewal TbLip Renewal CrtnLip Renewal Crtn

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65278-105-01Lip Renewal SPF 5014 g in 1 TUBEPASTE141
65278-105-02Lip Renewal SPF 5014 g in 1 CARTONPASTE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65278-105LIP RENEWAL SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE) PASTE [JUNE JACOBS LABS, LLC]1Current NDC, 2 package rows20240614_187cd4ad-781f-b0e4-e063-6394a90a414b.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65278-10565278-105-01, 65278-105-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
OCTINOXATE4Y5P7MUD51ACTIB
HYALURONIC ACIDS270N0TRQYIACT
WATER059QF0KO0RIACT
LIMONENE, (+)-GFD7C86Q1WIACT
AVOBENZONEG63QQF2NOXACTIB
MENTHOLL7T10EIP3AIACT
VANILLINCHI530446XIACT
LYCIUM BARBARUM FRUIT930626MWDLIACT
GLYCERYL DIISOSTEARATE68BAV42LRCIACT
DIMETHICONE92RU3N3Y1OIACT
GRAPE SEED OIL930MLC8XGGIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
DIISOSTEARYL MALATEQBS8A3XZGQIACT
SPEARMINT OILC3M81465G5IACT
CARVONE, (+/-)-75GK9XIA8IIACT
TRIISOSTEARIN71503RH8KGIACT
TOCOPHEROLR0ZB2556P8IACT
ASPALATHUS LINEARIS LEAFH7UGK1GJCUIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
GLYCERINPDC6A3C0OXIACT
CITRALT7EU0O9VPPIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
SHEA BUTTERK49155WL9YIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
ALLANTOIN344S277G0ZIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
JOJOBA OIL724GKU717MIACT
CARNAUBA WAXR12CBM0EIZIACT
SQUALANEGW89575KF9IACT
VITIS VINIFERA SEEDC34U15ICXAIACT

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
Lip Renewal SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATEJune Jacobs Labs, LLC187cd4ad-781f-b0e4-e063-6394a90a414b2024-05-15WarningsExact identifier
ndc (package): 65278-105-02
ndc (package): 65278-105-01
ndc (product): 65278-105
ndc11 (package): 65278010501
ndc11 (package): 65278010502
spl id: 187cd4ad-7820-b0e4-e063-6394a90a414b
spl set id: 187cd4ad-781f-b0e4-e063-6394a90a414b

Reported adverse events (FAERS/openFDA)#

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