FDA.reportPublic FDA data

Solar Plex 769.000 rev 1/769AA Ultra Sunscreen Lotion SPF 30

Manufacturer
Vi-Jon, LLC | Consumer Product Partners, LLC
Effective date
2025-05-06
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
legacy-cache
Hydrated at
2026-08-01 20:39:18

Label at a glance#

ProductAvobenzone, Homosalate, Octisalate, Octocrylene
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure14 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protections measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure apply to all skin exposed to the sun reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours ​Sun Protection Measures.  ​Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protect...

Storage and handling

Protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protections 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

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 if

OTC - STOP USE SECTION

  • rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • ​Sun Protection Measures. ​Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, ethylhexyl palmitate, sorbitol, polyamide-8, benzyl alcohol, tocopherol, caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, olethe-3, disodium EDTA

Disclaimer

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces

*Oxybenzone & Octinoxate free

**This product is not manufactured or distributed by Bayer, distributor of Coppertone Ultra GUARD Sunscreen Lotion Broad Spectrum SPF 30.

Adverse Reactions

ADVERSE REACTIONS SECTION

Manufactured by: Vi-Jon, Inc., 8515 Page Ave., St. Louis, MO 63114

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF 30

REEF FRIENDLY*

NDC 0869-0769-34

SOLAR PLEX™

ULTRA

SUNSCREEN

LOTION

Broad Spectrum SPF 30

Water Resistant (80 minutes)

Hypoallergenic

Dermatologist tested

Compare to Coppertone ®Ultra Guard Sunscreen Lotion**

8 FL OZ (236 mL)

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0869-0769AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION [VI-JON, LLC]15Legacy NDC20250507_791e308f-c6ff-4763-9554-5e8863bfffcb.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0869-07690869-0769-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ETHYLHEXYL PALMITATE2865993309IACT
SORBITOL506T60A25RIACT
POLYAMIDE-8 (4500 MW)77723GV81AIACT
BENZYL ALCOHOLLKG8494WBHIACT
TOCOPHEROLR0ZB2556P8IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CHLORPHENESINI670DAL4SZIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
OLETH-3BQZ26235UCIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML · Source PDF

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
4cd57e1d-28a3-4eb4-e063-6294a90a55d0791e308f-c6ff-4763-9554-5e8863bfffcb2026-03-12Warnings, Adverse reactionsExact identifier
spl set id: 791e308f-c6ff-4763-9554-5e8863bfffcb

Reported adverse events (FAERS/openFDA)#

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