FDA.reportPublic FDA data

360 by QUR Vanilla lace lip balm

Manufacturer
Qur, Inc
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:03

Label at a glance#

Product360 by QUR Vanilla lace lip balm
Active ingredientOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure7 sections

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every two hours. Use a water resistant sunscreen if swimming or sweating. For children under 6 months, consult a physician.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octyl methoxycinnamate 5%, Octocrylene 3%, Octisalate 2.2%, Avobenzone 0.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Spending time in the sun increase your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Skin Cancer/Skin Aging Alert:

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every two hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • For children under 6 months, consult a physician.

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Olea Europaea (Olive) Fruit Oil, Synthetic Wax, Hydrogenated Vegetable Oil, Cocos Nucifera (Coconut) Oil, Polybutene, Ethylhexyl Palmitate, Euphorbia Cerifera (Candelilla) wax, Bis-Diglyceryl Polyacyladipate-1, Butyrospermum Parkii (Shea Butter), Fragrance, Stevioside.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle5Bottle5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81761-115-01360 by QUR Vanilla lace lip balm4 g in 1 CASESTICK42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81761-115360 BY QUR VANILLA LACE LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) STICK [QUR, INC]2Current NDC, Legacy NDC, 1 package rows20231027_bedb4c53-adaa-3a8a-e053-2a95a90ae93a.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81761-11581761-115-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
COCONUT OILQ9L0O73W7LIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
ETHYLHEXYL PALMITATE2865993309IACT
CANDELILLA WAXWL0328HX19IACT
BIS-DIGLYCERYL POLYACYLADIPATE-1F6ZM55051MIACT
SHEA BUTTERK49155WL9YIACT
STEVIOSIDE0YON5MXJ9PIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB

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
360 by QUR Vanilla lace lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb4c53-adaa-3a8a-e053-2a95a90ae93a2023-10-26WarningsExact identifier
ndc (package): 81761-115-01
ndc (product): 81761-115
ndc11 (package): 81761011501
spl id: 089f2ad0-1f4a-d83c-e063-6294a90a34a7
spl set id: bedb4c53-adaa-3a8a-e053-2a95a90ae93a

Reported adverse events (FAERS/openFDA)#

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