FDA.reportPublic FDA data

Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40

Manufacturer
NATURA BISSE INTERNATIONAL SA
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:04

Label at a glance#

ProductDiamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

apply liberally 15 minutes before sun exposure. 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: Sun Protection Measures. limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses. children under 6 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 7.8%

Zinc oxide 25%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn.
  • If used as directed with other sun protection measures (see  ) decreases the risk of skin cancer and early skin aging caused by the sun. Directions

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally 15 minutes before sun exposure.

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: Sun Protection Measures.

  • 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: Ask a doctor
  • reapply at least every 2 hours.
  • use a water resistant sunscreen if swimming or sweating.

RECENT MAJOR CHANGES SECTION

Directions have changed from:

apply liberally 15 minutes before sun exposure.

reapply:

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: Sun Protection Measures.

To:

apply liberally 15 minutes before sun exposure.

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:

  • after 40 minutes of swimming or sweating
  • Immediately after tower drying
  • at least every 2 hours.
  • 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
  • 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: Ask a doctor
  • reapply at least every 2 hours.
  • use a water resistant sunscreen if swimming or sweating.

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, C15-19 Alkane, Butyloctyl Salicylate, Niacinamide, Dimethicone, Coco-Caprylate Propanediol, PEG-30 Dipolyhydroxystearate, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, Polyglyceryl-6 Polyhydroxystearate, Diisopropyl Sebacate, Polyhydroxystearic Acid, Sodium Chloride, Silica, Tocopheryl Acetate, Arginine, Artemia Extract, Tocopherol, Lysine, Ascorbyl Palmitate,Triethoxycaprylylsilane, Stearalkonium Hectorite, Polyglycerin-6, Disodium EDTA, Propylene Carbonate, Cetyl Alcohol, Ethylhexylglycerin, Sodium Lauroyl Glutamate, Magnesium Chloride, Phenoxyethanol, Potassium Sorbate, Fragrance, Iron Oxides.

Questions?

OTC - QUESTIONS SECTION

1-800-762-8872 M-F 9:00 AM to 5:00 PM

Package Labeling:63730-001-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

63730-001-01 Label63730-001-01 Label

Package Labeling:63730-001-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

63730-001-02 inner label63730-001-02 inner label63730-001-02 label63730-001-02 label63730-001-02 outer label63730-001-02 outer label

Package Labeling:63730-001-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

63730-001-03 outer label63730-001-03 outer label63730-001-03 inner label63730-001-03 inner label63730-001-03 label63730-001-03 label

Package Labeling:63730-001-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

63730-001-04 outer label63730-001-04 outer label63730-001-04 inner label63730-001-04 inner label63730-001-04 label63730-001-04 label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63730-001-01Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 404 mL in 1 PACKETLOTION44
63730-001-02Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 4010 mL in 1 TUBELOTION104
63730-001-02Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 401 in 1 BOXLOTION14
63730-001-03Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 401 in 1 BOXLOTION14
63730-001-03Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 4030 mL in 1 TUBELOTION304
63730-001-04Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 401 in 1 BOXLOTION14
63730-001-04Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 4030 mL in 1 TUBELOTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63730-001DIAMOND LUMINOUS UV DEFENSE LIGHT TINTED FLUID SUNSCREEN BROAD SPECTRUM SPF 40 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [NATURA BISSE INTERNATIONAL SA]4Current NDC, Legacy NDC, 7 package rows20231027_bf8b71c7-257b-0eb6-e053-2a95a90a3a4c.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63730-00163730-001-01, 63730-001-02, 63730-001-03, 63730-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
C15-19 ALKANECI87N1IM01IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
NIACINAMIDE25X51I8RD4IACT
DIMETHICONE92RU3N3Y1OIACT
COCO-CAPRYLATE4828G836N6IACT
PROPANEDIOL5965N8W85TIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
SODIUM CHLORIDE451W47IQ8XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ARGININE94ZLA3W45FIACT
TOCOPHEROLR0ZB2556P8IACT
LYSINEK3Z4F929H6IACT
ASCORBYL PALMITATEQN83US2B0NIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
POLYGLYCERIN-6M51422LRAMIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PROPYLENE CARBONATE8D08K3S51EIACT
CETYL ALCOHOL936JST6JCNIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM LAUROYL GLUTAMATENCX1UU2D33IACT
MAGNESIUM CHLORIDE02F3473H9OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
FERRIC OXIDE RED1K09F3G675IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDENATURA BISSE INTERNATIONAL SAbf8b71c7-257b-0eb6-e053-2a95a90a3a4c2023-10-26WarningsExact identifier
ndc (package): 63730-001-02
ndc (package): 63730-001-04
ndc (package): 63730-001-03
ndc (package): 63730-001-01
ndc (product): 63730-001
ndc11 (package): 63730000103
ndc11 (package): 63730000104
ndc11 (package): 63730000102
ndc11 (package): 63730000101
spl id: 08aaf4ce-9b1b-5491-e063-6294a90a8a4e
spl set id: bf8b71c7-257b-0eb6-e053-2a95a90a3a4c

Reported adverse events (FAERS/openFDA)#

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