FDA.reportPublic FDA data

SPF 30 SUNSCREEN LOTION

Manufacturer
Tekweld Solutions, Inc.
Effective date
2019-12-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:02:21

Label at a glance#

ProductSPF 30 SUNSCREEN
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
Label structure9 sections

Indications and uses

• Helps prevent sunburn

Dosage and administration

Apply generously & evenly before sun exposure.Reapply as needed or after towel drying, swimming, or sweating. Ask doctor before using on children under 6 months.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%,

Octisalate 2.0%,

Oxybenzone 4.0% 

Titanium Dioxide 2.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• Helps prevent sunburn

WARNINGS:

WARNINGS SECTION

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

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

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply generously & evenly before sun exposure.Reapply as needed or after towel drying, swimming, or sweating. Ask doctor before using on children under 6 months.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Cetearyl Alcohol, Xanthan Gum, C12-15 Alkyl Benzoate, Myristyl Propionate, Propylene Glycol, Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl Butylcarbamate, DMDM Hydantoin, Fragrance.

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

Questions or Comment ?

OTC - QUESTIONS SECTION

Call toll free 1-877-254-2281

Distributed By:

SPL UNCLASSIFIED SECTION

Tekweld: 45 Rabro Drive, Hauppauge, NY11788

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71160-014-002021-07-23C16284748780-1ab0e2407-3178-f274-e053-dbdaa90a6471SPF 30 SUNSCREEN LOTION
71160-014-002020-07-22C16284748780-1ab0e2407-3178-f274-e053-dbdaa90a6471SPF 30 SUNSCREEN LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71160-014-00SPF 30 SUNSCREEN15 mL in 1 BOTTLELOTION154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71160-014SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LOTION [TEKWELD SOLUTIONS, INC.]4Legacy NDC, 1 package rows20191227_569b8010-d2bb-4eda-90de-9ef8950823e2.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71160-01471160-014-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
XANTHAN GUMTTV12P4NEEIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MYRISTYL PROPIONATEP59053E7NJIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
DMDM HYDANTOINBYR0546TOWIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
9aa44d85-6708-a888-e053-2a95a90a3b6c569b8010-d2bb-4eda-90de-9ef8950823e22019-12-26WarningsExact identifier
spl id: 9aa44d85-6708-a888-e053-2a95a90a3b6c
spl set id: 569b8010-d2bb-4eda-90de-9ef8950823e2

Reported adverse events (FAERS/openFDA)#

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