4-IN-1 Broad Spectrum SPF 50 Sunscreen

Manufacturer
Bio Jouvance | Cosmetic Science Laboratories, LLC
Effective date
2020-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:28:50

Label at a glance#

Product4-IN-1 Broad Spectrum SPF 50 Sunscreen
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE
Label structure9 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see directions), decrease the risk of skin cancer and early skin aging caused by the sun.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Purpose Sunscreen

Avobenzone 3.0%, Homosalate 15%, Octocrylene 8.0%, Octisalate 5.0%, Oxybenzone 5.0%

Uses

OTC - PURPOSE SECTION

helps prevent sunburn

if used as directed with other sun protection measures (see directions), decrease the risk of skin cancer and early skin aging caused by the sun.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Stop use and ask a Physician if rash occurs.

WARNINGS SECTION

For external use only. Do not used on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • re-apply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two hours
  • Sun Protection Meaures. Spending time under the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regurlarly use a sunscreen with an SPF of 15 or higher, and other sun protection meaures, including:
  • limit time under the sun, especially from 10:00 a.m. to 2:00 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a Physician if exposure would be advised.

INACTIVE INGREDIENT SECTION

water, stearic acid, glyceryl stearate, PEG-100 stearate, elaeis guineensis kernel oil, aloe barbadensis leaft ectract, retinyl palmitate, pyridoxine hydrochloride cyanocobalamin, ascorbic acid, tocopheryl acetate, sodium hyaluronate crosspolymer, dimethicone, polysorbate 60, carbomer, triethanolamine, DMDM hydantoin, diazolidinyl urea, iodopropynyl butylcarbamate

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-272-1716

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIO JOUVANCE

PARIS

4-in-1 BROAD SPECTRUM SPF 50 SUNSCREEN

FACE/BODY

2 FL. OZ. 60 ml

DISTRIBUTED BY BIOJOUVANCE INC.

LOS ANGELES, CA 90039

WWW.BIOJOUVANCE.COM

4-IN-1 SPF 504-IN-1 SPF 50

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80030-001-012022-01-28C16284748780-1d6a99b39-6180-a426-e053-dadaa90af4c24-IN-1 Broad Spectrum SPF 50 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80030-001-014-IN-1 Broad Spectrum SPF 50 Sunscreen60 mL in 1 TUBECREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80030-0014-IN-1 BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) CREAM [BIO JOUVANCE]1Legacy NDC, 1 package rows20200910_ad3ff9fa-1de9-19ed-e053-2995a90a684e.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80030-00180030-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
ad3ff9fa-1dea-19ed-e053-2995a90a684ead3ff9fa-1de9-19ed-e053-2995a90a684e2020-08-19WarningsExact identifier
spl id: ad3ff9fa-1dea-19ed-e053-2995a90a684e
spl set id: ad3ff9fa-1de9-19ed-e053-2995a90a684e

Reported adverse events (FAERS/openFDA)#

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