FDA.reportPublic FDA data

Natural SPF 50

Product NDC
68062-8307
11-digit product format
680628307
Labeler code
68062
Product ID
68062-8307_5b8dd5df-084e-2ba7-e063-6394a90aaeac
Type
HUMAN OTC DRUG
Nonproprietary name
titanium dioxide, zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Spa de Soleil
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-04
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
780; 900 mg/118mL; mg/118mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Natural SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE780 mg/118mL
ZINC OXIDE900 mg/118mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68062-8307-1Natural SPF 50118 mL in 1 BOTTLE, PUMPLOTION1187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68062-8307NATURAL SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [SPA DE SOLEIL]6Current NDC, Legacy NDC, 1 package rows20250104_4eb87d1e-601a-1209-e054-00144ff8d46c.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 110 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DAY DEFENSE TINTEDTITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad4442-e45f-90e2-e063-6294a90aeef52025-12-17Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d8b849-cf73-e008-e063-6394a90a410a2025-12-17Exact identifier
application number: M020
TINTED RESTORATIVE MOISTURIZERZINC OXIDESKINERGIX LLC3636adf0-c3bd-7422-e063-6394a90aaccc2025-12-17Exact identifier
application number: M020
Premier ZincZINC OXIDEENSO SKINCARE & WELLNESS LLC3bb378c8-14b0-aa13-e063-6294a90a4db32025-12-17WarningsExact identifier
application number: M020
Protect and RenewZINC OXIDEENSO SKINCARE & WELLNESS LLC3bb479ed-1153-8e80-e063-6294a90a29372025-12-17WarningsExact identifier
application number: M020
Flawless FinishTITANIUM DIOXIDE, ZINC OXIDEENSO SKINCARE & WELLNESS LLC3b8df7ce-e5ce-aaf8-e063-6394a90afdae2025-12-17WarningsExact identifier
application number: M020
Shield Mineral Sunscreen TintedZINC OXIDESMOOTHE LLC369b9d76-f6c3-e25f-e063-6294a90adaf32025-12-17Exact identifier
application number: M020
Shield Mineral Sunscreen Non TintedZINC OXIDESMOOTHE LLC369bc20d-7192-7c0a-e063-6294a90a3dfe2025-12-17Exact identifier
application number: M020
Lip BalmTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369d63a9-b9a9-9530-e063-6394a90ac8ef2025-12-17Exact identifier
application number: M020
Matte TintTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369ced69-59b4-0f3c-e063-6294a90a582f2025-12-17Exact identifier
application number: M020
Hydra TintZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369d4e7a-8356-8f15-e063-6394a90acca82025-12-17Exact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b0ac77-13d8-4259-e063-6394a90a893b2025-12-17Exact identifier
application number: M020
Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b000e3-2516-932c-e063-6294a90a0e412025-12-17Exact identifier
application number: M020
Moisturizing Mineral Sunscreen TintedZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b12dbc-5edc-aad1-e063-6394a90a42ea2025-12-17Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b1a6c8-b4ff-089a-e063-6394a90a24692025-12-17Exact identifier
application number: M020
Badger SPF 40 Tinted Mineral FaceZINC OXIDEW.S. Badger Company, Inc.4628c04f-b7a6-b3fe-e063-6294a90a16752025-12-17WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc0a5a4d0e-8ab2-3d79-e063-6394a90a70062025-12-17WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 10%, OCTOCRYLENE 5%Beiersdorf Inc0a5a42a3-6fe4-2980-e063-6394a90a54fe2025-12-17WarningsExact identifier
application number: M020
Coppertone Glow Suncreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdord Incb65c117d-f200-bb22-e053-2995a90ab71d2025-12-17WarningsExact identifier
application number: M020
Covergirl Clean Fresh Tinted Lip Balm Glowing Protection SPF 15 Mineral Sunscreen - All shadesZINC OXIDE AND TITANIUM DIOXIDENoxell2cdbeb73-b805-f144-e063-6294a90a088d2025-12-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68062-8307-168062830701118 mL in 1 BOTTLE, PUMP (68062-8307-1) 118 ml2017-05-040000-00-00NoNoCurrent