FDA.reportPublic FDA data

Super Lysine Plus Coldstick

Manufacturer
Quantum, Inc. | Sun Deep Inc.
Effective date
2025-10-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:40:35

Label at a glance#

ProductSuper Lysine Plus Coldstick
Active ingredientOCTINOXATE, OXYBENZONE
Label structure9 sections

Indications and uses

Helps protect against sunburn and chapped lips.

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. Children under 6 months: ask a doctor.

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Octinoxate 7.0%Sunscreen
Oxybenzone (Benzophenone-3) 5.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps protect against sunburn and chapped lips.

Warnings

WARNINGS SECTION

  • Skin Cancer/Skin Aging Alert:Spending time in the sun increases 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.
  • For external use only.

OTC - DO NOT USE SECTION

  • Do not useon damaged or broken skin.

OTC - STOP USE SECTION

  • Stop use and consult a doctorif rash occurs.
  • Avoid contact with eyes.If in eyes, rinse with warm water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.

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. Children under 6 months: ask a doctor.

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Calendula Officinalis Extract, Carthamus Tinctorius (Safflower) Seed Oil, Cholecalciferol (Vitamin D), Copernicia Cerifera (Carnauba) Wax, Echinacea Purpurea Extract, Gum Benzoin Tincture, Hydrastis Canadensis (Goldenseal) Leaf, Lysine, Melaleuca Alternifolia (Tea Tree) Oil, Melaleuca Cajuputi (Cajeput) Oil, Propolis Extract, Purified Water, Retinyl Palmitate (Vitamin A), Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Tocopheryl Acetate (Vitamin E).

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: QUANTUM, INC.
PO BOX 2791, EUGENE, OR 97402

PRINCIPAL DISPLAY PANEL - 5 g Cylinder Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quantum ®
HEALTH

SuperLysine + ®

ColdStick
LIP TREATMENT & PROTECTANT

SOOTHES & MOISTURIZES
CHAPPED LIPS

SOFTENS & PROTECTS

GOES ON CLEAR

LYSINE PLUSHERBS & NUTRIENTS

SPF 21
SUNSCREEN

NET WT 5g / .17 OZ

PRINCIPAL DISPLAY PANEL - 5 g Cylinder Blister Pack
PRINCIPAL DISPLAY PANEL - 5 g Cylinder Blister Pack

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70084-220-012025-01-30C16284748780-1ba0f9c33-5736-a910-e053-dadaa90a0b85Super Lysine + ® Coldstick
70084-220-012025-01-30C16284748780-1ba0f9c33-5736-a910-e053-dadaa90a0b85Super Lysine + ® Coldstick
70084-220-012023-02-13C16284748780-1ba0f9c33-5736-a910-e053-dadaa90a0b85Super Lysine + ® Coldstick
70084-220-012023-02-13C16284748780-1ba0f9c33-5736-a910-e053-dadaa90a0b85Super Lysine + ® Coldstick
70084-220-012021-01-29C16284748780-1ba0f9c33-5736-a910-e053-dadaa90a0b85Super Lysine + ® Coldstick
70084-220-012021-01-29C16284748780-1ba0f9c33-5736-a910-e053-dadaa90a0b85Super Lysine + ® Coldstick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70084-220-01Super Lysine Plus Coldstick5 g in 1 CYLINDERLIPSTICK54

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70084-22070084-220-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ECHINACEA PURPUREAQI7G114Y98IACT
BENZOIN RESINGK21SBA74RIACT
GOLDENSEALZW3Z11D0JVIACT
LYSINE HYDROCHLORIDEJNJ23Q2COMIACT
TEA TREE OILVIF565UC2GIACT
MELALEUCA CAJUPUTI LEAF OIL5O59RMR6DUIACT
PROPOLIS WAX6Y8XYV2NOFIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SAFFLOWER4VBL71TY4YIACT
CHOLECALCIFEROL1C6V77QF41IACT
CARNAUBA WAXR12CBM0EIZIACT
WATER059QF0KO0RIACT
CASTOR OILD5340Y2I9GIACT
JOJOBA OIL724GKU717MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TOCOPHEROLR0ZB2556P8IACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32023-02-07full-release2026-05-31 23:54:04

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
Super Lysine Plus ColdstickOCTINOXATE AND OXYBENZONEQuantum, Inc.c9318a8c-ba3b-4068-84df-110c9005ee1d2025-10-20WarningsExact identifier
ndc (package): 70084-220-01
ndc (product): 70084-220
ndc11 (package): 70084022001
spl id: 419d9734-9a94-c984-e063-6294a90a2dc1
spl set id: c9318a8c-ba3b-4068-84df-110c9005ee1d

Reported adverse events (FAERS/openFDA)#

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