FDA.reportPublic FDA data

Traci Lynn Skin

Manufacturer
Prime Enterprises
Effective date
2020-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:21

Label at a glance#

ProductTraci Lynn Skin Iluminator Broad Spectrum SPF 50
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure9 sections

Indications and 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

Dosage and administration

Apply liberally 15 minutes before sun exposure. 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 broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Zinc Oxide 9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • 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 keeo out of the eyes.

Rinse with water to remove.

Stop use and ask a doctor if arash occurs

Kep out of reach of children if product is walloed, get medical help or contact a Poison Control Center right away

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Butylene Glycol, Cyclopentasiloxane, Ethylhexyl Stearate, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Isopropyl Palmitate, Niacinamide, Octyldodecyl Neopentanoate, Oleth-3 Phosphate, PEG-7 Trimethylolpropane Coconut Ether, Phenoxyethanol, Polyisobutene, Sodium Hyaluronate, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

Other information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Mafactured for TRACI LYNN BEAUTY, LLC

954.717.4448 / www.tracilynnbeauty.com

Traci Lynn Skin Illuminator Sunscreen Broad Spectrum SPF 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0296-32023-01-30C16284748780-1f386c649-e5e4-0266-e053-dadaa90a7c1aTraci Lynn Skin Illuminator Sunscreen Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0296-3Traci Lynn SkinIluminator Broad Spectrum SPF 5050 mL in 1 BOTTLE, PUMPLOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0296TRACI LYNN SKIN ILUMINATOR BROAD SPECTRUM SPF 50 (OCTINOXATE, ZINC OXIDE) LOTION [PRIME ENTERPRISES]1Legacy NDC, 1 package rows20200502_a496f144-1a6a-225c-e053-2a95a90ae449.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-029658443-0296-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
TRIMETHYLOLPROPANE090GDF4HBDIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
NIACINAMIDE25X51I8RD4IACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
a496edd5-f58c-285a-e053-2a95a90acdfea496f144-1a6a-225c-e053-2a95a90ae4492020-05-01WarningsExact identifier
spl id: a496edd5-f58c-285a-e053-2a95a90acdfe
spl set id: a496f144-1a6a-225c-e053-2a95a90ae449

Reported adverse events (FAERS/openFDA)#

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