FDA.reportPublic FDA data

CB 101

Manufacturer
Tekweld Solutions, Inc.
Effective date
2019-04-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:05

Label at a glance#

ProductCB 101
Active ingredientOCTINOXATE, OXYBENZONE
Label structure15 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients:
Octinoxate 7.5%
Oxybenzone 3.5%

OTC - PURPOSE SECTION

Purpose:
Octinoxate ..............................Sunscreen
Oxybenzone ...........................Sunscreen

INDICATIONS & USAGE SECTION

Uses:

  • Helps prevent sunburn

WARNINGS SECTION

Warnings
• 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.

OTHER SAFETY INFORMATION

For external use only.

OTC - DO NOT USE SECTION

Do not use on broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask doctor: if rash or irritation develops and persists.

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 right away.

DOSAGE & ADMINISTRATION SECTION

Directions
• Apply liberally 15 minutes before sun exposure as needed
• Children under 6 months of age: ask a doctor before use.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Petrolatum, Ozokerite, Mineral Oil, Microcrystalline Wax, Paraffin, Lanolin,
Copernicia Cerifera (Carnauba) Wax, Tocopherol,
Propylparaben, Methylparaben, Aloe Barbadensis Leaf Extract.

OTHER SAFETY INFORMATION

Other information
• Protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or comments? www.tekweld.com                MADE IN USA

Product Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF15 Natural • Aloe Vera • Safety Sealed

Peel Back for Drug Facts

Net Wt. 0.15 oz (4.25g)
Distributed by: Tekweld 45 Rabro Dr. Hauppauge, NY 11788

CB 101 Lip BalmCB 101 Lip Balm

res

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71160-191-012021-01-29C16284748780-1ba0f9c33-437d-a910-e053-dadaa90a0b85SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71160-191-01CB 1014.25 g in 1 TUBELIPSTICK4.251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71160-191CB 101 (SPF 15 LIP BALM) LIPSTICK [TEKWELD SOLUTIONS, INC.]1Legacy NDC, 1 package rows20190404_909f94c4-2d86-4a25-a9bd-45f5f933ee91.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71160-19171160-191-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
PETROLATUM4T6H12BN9UIACT
CERESINQ1LS2UJO3AIACT
MINERAL OILT5L8T28FGPIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PARAFFINI9O0E3H2ZEIACT
LANOLIN7EV65EAW6HIACT
CARNAUBA WAXR12CBM0EIZIACT
TOCOPHEROLR0ZB2556P8IACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
5a0d5998-4aad-46ae-b8ad-63f380347db9909f94c4-2d86-4a25-a9bd-45f5f933ee912019-04-03WarningsExact identifier
spl id: 5a0d5998-4aad-46ae-b8ad-63f380347db9
spl set id: 909f94c4-2d86-4a25-a9bd-45f5f933ee91

Reported adverse events (FAERS/openFDA)#

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