FDA.reportPublic FDA data

SPF 30 Sunscreen Lotion

Manufacturer
Tekweld Solutions, Inc.
Effective date
2023-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:05:51

Label at a glance#

ProductSPF 30 Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure11 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

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 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, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine,Disodium EDTA

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

71160-331-30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

71160-331-31

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

71160-331-32

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

71160-331-60

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71160-331-30SPF 30 Sunscreen30 mL in 1 BOTTLELOTION301
71160-331-30SPF 30 Sunscreen1 in 1 CARTONLOTION11
71160-331-31SPF 30 Sunscreen30 mL in 1 BOTTLELOTION301
71160-331-31SPF 30 Sunscreen1 in 1 CARTONLOTION11
71160-331-32SPF 30 Sunscreen1 in 1 CARTONLOTION11
71160-331-32SPF 30 Sunscreen30 mL in 1 BOTTLELOTION301
71160-331-60SPF 30 Sunscreen60 mL in 1 BOTTLELOTION601
71160-331-60SPF 30 Sunscreen1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71160-331SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [TEKWELD SOLUTIONS, INC.]1Current NDC, 8 package rows20231228_ea9f4d57-b00c-48ce-b833-9690be98bffd.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71160-33171160-331-30, 71160-331-31, 71160-331-32, 71160-331-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
LEVOMENOL24WE03BX2TIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB

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
SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATETekweld Solutions, Inc.ea9f4d57-b00c-48ce-b833-9690be98bffd2023-12-26WarningsExact identifier
ndc (package): 71160-331-32
ndc (package): 71160-331-60
ndc (package): 71160-331-30
ndc (package): 71160-331-31
ndc (product): 71160-331
ndc11 (package): 71160033132
ndc11 (package): 71160033160
ndc11 (package): 71160033131
ndc11 (package): 71160033130
spl id: 0d7021f4-3029-3554-e063-6294a90a64d4
spl set id: ea9f4d57-b00c-48ce-b833-9690be98bffd

Reported adverse events (FAERS/openFDA)#

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