FDA.reportPublic FDA data

Double Use Compact SPF 15 gold deluxe edition Medium 5

Product NDC
14141-203
11-digit product format
141410203
Labeler code
14141
Product ID
14141-203_3804885d-170e-97e6-e063-6294a90a59fc
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Titanium dioxide, Zinc Oxide
Dosage form
POWDER
Route
TOPICAL
Labeler
Bel Star S.A. (Colombia)
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-12
Substance
ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE
Active strength
4.9; 6.24; 3 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Double Use Compact SPF 15 gold deluxe edition Medium 5
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE4.9 g/100g
TITANIUM DIOXIDE6.24 g/100g
OCTINOXATE3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b3747373-ef67-89ff-e053-2995a90afcdeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-203-01Double Use Compact SPF 15 gold deluxe edition Medium 510 g in 1 BOTTLEPOWDER104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14141-203DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 1-2-3 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) POWDER DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 4 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) POWDER DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 5 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) POWDER DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 6 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) POWDER DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 7 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) POWDER [BEL STAR S.A. (COLOMBIA)]3Current NDC, Legacy NDC, 1 package rows20241030_b3747373-ef67-89ff-e053-2995a90afcde.zip

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 268 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF30 EVERYDAY/YEAR-ROUND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYd4f30d95-4a3f-49ad-817e-faa86fca50182024-11-07WarningsExact identifier
application number: M020
Round Lab Birch Juice Moisturizing UVLOCK Sun CushionZINC OXIDESEORIN COMPANY Co., Ltd.26407b83-b417-6450-e063-6294a90ad2b12024-11-06WarningsExact identifier
application number: M020
e.l.f. Holy Hydration Face Cream SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Incb7898d65-df86-580a-e053-2a95a90a5b1b2024-11-06WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acda604c-27cf-d500-e053-2995a90a5d652024-11-06WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acb92160-1749-d51b-e053-2995a90a9e872024-11-06WarningsExact identifier
application number: M020
Bondi Sands Toasted Coconut Lip Balm with SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acb8513e-723b-b7d6-e053-2995a90aed522024-11-06WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free Face SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acda9863-ad9f-e430-e053-2995a90a69a62024-11-06WarningsExact identifier
application number: M020
Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad SpectrumHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONESEORIN COMPANY Co., Ltd.26442417-f238-1fc3-e063-6394a90a6f822024-11-06WarningsExact identifier
application number: M020
Avene Mineral Sunscreen Face and BodyZINC OXIDEPierre Fabre USA Inc.fb5b1e94-bed3-8486-e053-6294a90a3a842024-11-06WarningsExact identifier
application number: M020
Avene Cleanance Mattifying SPF 30ZINC OXIDEPierre Fabre USA Inc.2644f545-0625-7858-e063-6394a90a59632024-11-06WarningsExact identifier
application number: M020
SPF30 CALENDULA SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY64580be7-868c-40fb-b7b8-840b417b25d32024-11-06WarningsExact identifier
application number: M020
KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY20ebe264-2f79-4eef-b83d-3f09a3ca28982024-11-06WarningsExact identifier
application number: M020
Cream Oil SunscreenZINC OXIDE, TITANIUM DIOXIDE SUNSCREENOwen Biosciences, Inc.b2ccdfea-1c27-42af-b9d8-752e9f91ae872024-11-05WarningsExact identifier
application number: M020
Vivant Day Treatment SPF 15OCTINOXATE 7.50% OCTISALATE 5.00%Vivant Pharmaceuticals, LLC10a95d0a-366f-0611-e063-6294a90abb442024-11-05WarningsExact identifier
application number: M020
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.1560a6b6-8d4a-6942-e063-6294a90a4a442024-11-04WarningsExact identifier
application number: M020
Bali Body Watermelon Tanning Oil SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd07d96576-fd78-acf3-e063-6394a90af45b2024-11-03WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Dry-Touch Face and Body Sunscreen Broad Spectrum UVA-UVB SPF 50ZINC OXIDEKenvue Brands LLC8f34c1f6-51fe-4719-ba1f-1e23c05e937b2024-11-01WarningsExact identifier
application number: M020
Byoma Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEBYOMA LIMITED25de7939-3b18-7f9e-e063-6394a90a23a92024-11-01WarningsExact identifier
application number: M020
Dr Edward Krulig New Melan Sunblock SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEKRULIG INTERNATIONAL, INC21c301d2-b283-40e1-bf26-b4bdde2782472024-10-31WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Broad-Spectrum Sunscreen SPF 50ZINC OXIDEZO Skin Health, Inc.f218c158-19aa-ab90-e053-2a95a90aaef32024-10-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14141-203-011414102030110 g in 1 BOTTLE (14141-203-01) 10 g2020-11-120000-00-00NoNoCurrent