SPF 30 Sunscreen Spray

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 23:02:19

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.

Contacts and useful links#

PhoneLabel contact877-254-2281

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%,

Octisalate 5.0%,

Oxybenzone 2.0%

Titanium Dioxide 2.5%

Soybean oil 3%

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.

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

Insect Repellent Active Ingredient: Soybean oil 3% Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Microcrystalline cellulose, C12-15 Alkyl Benzoate, Isooctyl Palmitate, Propylene Glycol, Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl Butylcarbamate, DMDM Hydantoin, Fragrance.

Drug Questions:

OTC - QUESTIONS SECTION

877-254-2281

Distributed By:

SPL UNCLASSIFIED SECTION

Tekweld: 45 Rabro Drive, Hauppauge, NY11788

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71160-011-00	2021-07-23	C162847	48780-1	ab0e2407-291a-f274-e053-dbdaa90a6471	SPF 30 Sunscreen Spray
71160-011-00	2020-07-22	C162847	48780-1	ab0e2407-291a-f274-e053-dbdaa90a6471	SPF 30 Sunscreen Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71160-011-00	SPF 30 Sunscreen	10 mL in 1 BOTTLE	SPRAY, SUSPENSION	10		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71160-011	SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) SPRAY, SUSPENSION [TEKWELD SOLUTIONS, INC.]	4	Legacy NDC, 1 package rows	20191227_060d7b56-1fdc-47f8-8a7f-49fe781dc0f4.zip

Products#

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

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

SPF 30 Sunscreen
OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
WATER
MICROCRYSTALLINE CELLULOSE
ALKYL (C12-15) BENZOATE
ISOCETYL PALMITATE
PROPYLENE GLYCOL
GLYCERYL STEARATE CITRATE
EDETATE DISODIUM ANHYDROUS
IODOPROPYNYL BUTYLCARBAMATE
DMDM HYDANTOIN
OCTINOXATE
OCTISALATE
OXYBENZONE
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71160-011	71160-011-00

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
Name	UNII	Kind
WATER	059QF0KO0R	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
ISOCETYL PALMITATE	355356620Z	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
GLYCERYL STEARATE CITRATE	WH8T92A065	IACT
EDETATE DISODIUM ANHYDROUS	8NLQ36F6MM	IACT
IODOPROPYNYL BUTYLCARBAMATE	603P14DHEB	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9aa4504b-ebf2-3f18-e053-2995a90a0abf			060d7b56-1fdc-47f8-8a7f-49fe781dc0f4	2019-12-26	Warnings	Exact identifier spl id: 9aa4504b-ebf2-3f18-e053-2995a90a0abf spl set id: 060d7b56-1fdc-47f8-8a7f-49fe781dc0f4

Reported adverse events (FAERS/openFDA)#

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