FDA.reportPublic FDA data

Luminous Defense SPF 50

Manufacturer
Levels 2 Skin
Effective date
2024-09-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:49:37

Label at a glance#

ProductLuminous Defense SPF 50
Active ingredientZINC OXIDE
Label structure10 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

Shake well before use Apply generously 15 minutes before sun exposure Reapply: after 40 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 of 15 or higher and other sun protection measures including: ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use
  • Apply generously 15 minutes before sun exposure
  • Reapply:
  • after 40 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 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 of age, ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, C12-15 Alkyl Benzoate, Jojoba Esters, Caprylic/Capric Triglyceride, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Propanediol, Tridecyl Salicylate, Niacinamide, Methylpropanediol, Silica, Bakuchiol, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Sodium Chloride, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Stearalkonium Hectorite, Lecithin, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Phenylpropanol, Nylon-12, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide.

Other Information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Contact Info@Levels2Skin.com

Company Information

SPL UNCLASSIFIED SECTION

Manufactured For Levels 2 Skin, LLC | Atlanta, GA 30316 | Levels2Skin.com | info@levels2skin.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84163-056-15Luminous Defense SPF 5030 mL in 1 BOTTLE, PLASTICLOTION302
84163-056-15Luminous Defense SPF 501 in 1 BOXLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84163-056LUMINOUS DEFENSE SPF 50 (ZINC OXIDE) LOTION [LEVELS 2 SKIN]2Current NDC, 2 package rows20250101_22e177b3-beea-212e-e063-6394a90a1452.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84163-05684163-056-15

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
ALLANTOIN344S277G0ZIACT
ZINC OXIDESOI2LOH54ZACTIB
LECITHIN, SUNFLOWER834K0WOS5GIACT
SODIUM HYDROXIDE55X04QC32IIACT
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE687U3PEB2YIACT
NIACINAMIDE25X51I8RD4IACT
METHYLPROPANEDIOLN8F53B3R4RIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
CAPRYLYL GLYCOL00YIU5438UIACT
RICE BRANR60QEP13ICIACT
NYLON-12446U8J075BIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
PROPANEDIOL5965N8W85TIACT
PHENYLPROPANOL0F897O3O4MIACT
ROSEMARYIJ67X351P9IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
BAKUCHIOLOT12HJU3ARIACT
COCO-CAPRYLATE4828G836N6IACT
SODIUM CHLORIDE451W47IQ8XIACT
LEVOMENOL24WE03BX2TIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT

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
Luminous Defense SPF 50ZINC OXIDELevels 2 Skin22e177b3-beea-212e-e063-6394a90a14522024-09-24WarningsExact identifier
ndc (package): 84163-056-15
ndc (product): 84163-056
ndc11 (package): 84163005615
spl id: 22e2c298-3029-c3c9-e063-6394a90a673b
spl set id: 22e177b3-beea-212e-e063-6394a90a1452

Reported adverse events (FAERS/openFDA)#

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