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 154 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Super Leaves Lip Balm SPF15 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ff1fc0-9ac5-2c9a-e063-6294a90a46322025-12-02WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 CoconutZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ff5675-fd8d-b665-e063-6294a90a1e0b2025-12-02WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 PineappleZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ffb35b-80f4-7ddb-e063-6394a90a2cbb2025-12-02WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC44ffd469-0205-846f-e063-6294a90af6b52025-12-02WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.daf0291e-770c-eaf2-e053-2a95a90a0b672025-12-01WarningsExact identifier
application number: M020
Centellian24 Madeca Derma Shield Vital Dewy SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTROCRYLENE7054144e0098c-170f-ca51-e063-6294a90aed202025-12-01WarningsExact identifier
application number: M020
Centellian24 Madeca Derma Shield Vital Sun EssenceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE7054144e194cd-ea61-71b3-e063-6394a90ac4862025-12-01WarningsExact identifier
application number: M020
Venture Performance Sun Protection Mineral Sunscreen SPF 50ZINC OXIDEVenture Performance Inc630fc5c2-a315-4e26-9bd9-5f8533d759082025-12-01WarningsExact identifier
application number: M020
EMINENCE Red Currant Protective MoisturizerOCTINOXATE, ZINC OXIDEEminence Organic Skin Care7eca62af-6f70-44ec-879e-74712163c4e02025-12-01WarningsExact identifier
application number: M020
CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless PrimerAVOBENZONE, OCTINOXATE, OCTISALATE AND OCTOCRYLENECharlotte Tilbury Beauty Ltd.2b215ecb-7c3a-63db-e063-6394a90aa88f2025-12-01WarningsExact identifier
application number: M020
P.CALM Water Barrier Sunscreen SPF 50 Broad SpectrumHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONELIFE WITHCORPORATION Inc.44ea9fb4-8e01-6969-e063-6294a90a6a942025-12-01WarningsExact identifier
application number: M020
ROC MULTI CORREXION - EVEN TONE AND LIFT - 5-In-1 Chest, Neck, and Face Cream Sunscreen - Broad Spectrum SPF 30AVOBENZONE, HOMOSALATA, OCTISALATE, OCTOCRYLENERoc Skincare2b3656d6-4b3a-9ef2-e063-6294a90acaa62025-12-01WarningsExact identifier
application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONERare Beauty Brands Inc.44ec0db5-4437-e4a3-e063-6294a90a9a002025-12-01WarningsExact identifier
application number: M020
RoC Retinol Correxion Wrinkle Correct Daily Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoC Skincare2888a198-116b-8441-e063-6394a90a0f952025-12-01WarningsExact identifier
application number: M020
ReefSafe Very High Sun Protection sunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44ec619f-ed3b-2fd3-e063-6294a90a858b2025-12-01WarningsExact identifier
application number: M020
Reef safe - Face and Body sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED38603298-e8da-e4c7-e063-6394a90aca3b2025-12-01WarningsExact identifier
application number: M020
ReefSafe Baby and Toddlers Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44dd513e-ebaa-0d6a-e063-6394a90a78b72025-11-30WarningsExact identifier
application number: M020
Safe4Kidz Natural Mineral Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44ddc0ae-a977-3adf-e063-6294a90a08982025-11-30WarningsExact identifier
application number: M020
Safe4Kidz Baby Zinc Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44ddc4d8-3f3b-5d11-e063-6294a90ae88a2025-11-30WarningsExact identifier
application number: M020
Clarite Makeup Foundation for a Clearer Appearance SPF 30 170-NOCTINOXATE, ZINC OXIDEBEL STAR S Ab56f5883-be57-e0e5-e053-2a95a90adb0c2025-11-29WarningsExact 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