Defend Hydrating Broad Spectrum SPF 15

Manufacturer
Profile 4 Men LLC | PhytogenX, Inc.
Effective date
2016-04-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:45:50

Label at a glance#

ProductDefend Hydrating Broad Spectrum SPF 15
Active ingredientHOMOSALATE, AVOBENZONE, OCTISALATE
Label structure6 sections

Dosage and administration

Apply to neck and face before exposure to the sun and the light of day. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating, reapply at least every two hours. Children under 6 months. Ask a doctor. USE ONLY AS DIRECTED. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularaly use a sunscreen with a Broad ...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Homosolate..............................8.0%
 Avobenzone ............................3.0%Purpose: Sunscreen
Octisalate.................................5.0%

SPL UNCLASSIFIED SECTION

Uses:

  • Helps Prevent Sunburn
  • If Used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings:

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin.

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

​Stop use and ask a doctor​ if rash occurs.

​Keep out of reach of children.​ If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

INDICATIONS & USAGE SECTION

  • Apply to neck and face before exposure to the sun and the light of day.
  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating, reapply at least every two hours.
  • Children under 6 months. Ask a doctor.

USE ONLY AS DIRECTED.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularaly use a sunscreen with a Broad Spectrum value of SPF 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10 a.m.-2p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Silica, Caprylic/Capric Triglyceride, Glycerin, Xylitylglucoside, Anhydroxylitol, Xylitol, Chondrus Crispus Extract, Sodium Hyaluronate, Glyceryl Stearate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Tocopheryl Acetate, Ilex Paraguariensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Vegetable Collagen, Stearic Acid, Polymethyl Methacrylate, Di-C12-15 Alkyl Fumarate, Cetyl Phosphate, Disodium EDTA, Carbomer, Fragrance, Aminomethyl Propanol, Phenoxyethanol, Caprylyl Glycol, Potassium Sorbate, Hexylene Glycol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MADE IN USA OF DOMESTIC AND FOREIGN COMPONENTS

DISTRIBUTED BY:
PROFILE 4 MEN LLC
NAPLES, FL 34108 USA

​ PROFILE4MEN.COM

CartonCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70384-100-012020-01-31C16284748780-19d75b9d0-77d1-f424-e053-dadaa90a57ceDefend Hydrating Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70384-100-01Defend Hydrating Broad Spectrum SPF 151 in 1 PACKAGECREAM12
70384-100-01Defend Hydrating Broad Spectrum SPF 1575 mL in 1 TUBECREAM752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70384-100DEFEND HYDRATING BROAD SPECTRUM SPF 15 (SPF 15 SUNSCREEN) CREAM [PROFILE 4 MEN LLC]2Legacy NDC, 2 package rows20160502_63a9928c-43c1-4237-9e64-fb934721e6ae.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70384-10070384-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

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
772b1bda-1b91-47c3-aead-b2d1d4a328f063a9928c-43c1-4237-9e64-fb934721e6ae2016-04-18WarningsExact identifier
spl id: 772b1bda-1b91-47c3-aead-b2d1d4a328f0
spl set id: 63a9928c-43c1-4237-9e64-fb934721e6ae

Reported adverse events (FAERS/openFDA)#

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