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 39 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDRA SPF 34HOMOSALATE, OCTYL SALICYLATE, AVOBENZONEDrmtlgy, LLC31e41ed5-8498-4e2d-928a-c15ca99775e42026-04-21WarningsExact identifier
application number: M020
FORGESKINMINERAL TALLOW SUNSCREENGUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD4fe913f4-b0be-dc53-e063-6294a90a363c2026-04-20WarningsExact identifier
application number: M020
ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.228dcd68-aaba-0451-e063-6394a90a8ad02026-04-20WarningsExact identifier
application number: M020
Biore Aqua Rich UVOCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKAO USAf900db18-5fe2-1d74-e053-6394a90a3ca22026-04-20WarningsExact identifier
application number: M020
Biore UV Aqua RichOCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKAO USA2bc23bb5-86bb-7915-e063-6394a90a9d722026-04-20WarningsExact identifier
application number: M020
ETUDE SunPrise Mild Airy Finish SunstickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEETUDE CORPORATION25abc744-5b62-acb4-e063-6394a90af1102026-04-19WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7c399-b05e-2545-e053-2995a90ac6112026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7c399-b060-2545-e053-2995a90ac6112026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7d9f4-986f-70f7-e053-2a95a90a4f8a2026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c81845-afcb-18ac-e053-2a95a90abdbe2026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c83245-a40c-8f05-e053-2a95a90a05212026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c84047-fd3b-ea66-e053-2a95a90ae9aa2026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c623aa-3846-b7f4-e053-2995a90aecb52026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c585ff-88de-e29c-e053-2a95a90af4d42026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c852de-4c36-6d93-e053-2995a90aff612026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c86288-bb22-03b1-e053-2995a90a31612026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8742f-1060-48bc-e053-2995a90a31c22026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c4eedc-12a0-6418-e053-2a95a90a55e72026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8849a-6624-6987-e053-2a95a90a45462026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8ac70-a8c8-2f07-e053-2a95a90a3d012026-04-18WarningsExact 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