FDA.reportPublic FDA data

SPF 50 Mineral Sunscreen

Product NDC
72667-101
11-digit product format
726670101
Labeler code
72667
Product ID
72667-101_374d7396-31f7-8fd6-e063-6394a90ab10e
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Inspec Solutions, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-03
Substance
ZINC OXIDE
Active strength
20 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
SPF 50 Mineral Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
36af9a0a-536b-ee1a-e063-6394a90aace4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72667-101-01SPF 50 Mineral Sunscreen50 g in 1 TUBELOTION502
72667-101-02SPF 50 Mineral Sunscreen177 g in 1 TUBELOTION1772

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 123 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYLOTROL PAIN RELIEVINGLIDOCAINE HCL, MENTHOLAsclemed USA, Inc.1553351c-aee8-4c40-9548-35cce246bda92024-10-25WarningsExact identifier
application number: M017
OutgroBENZOCAINEMedtech Products Inc.d6be8a1d-aca7-42b1-86da-881d42ffe8d52024-10-25WarningsExact identifier
application number: M017
Monistat Complete Care Instant Itch ReliefHYDROCORTISONEInsight Pharmaceuticals LLCa0f40504-6183-4f32-8d17-6586b3f386a62024-10-25WarningsExact identifier
application number: M017
Boil EaseBENZOCAINEInsight Pharmaceuticals LLCbf108934-5e1a-4059-9dcf-008f52a83fab2024-10-25WarningsExact identifier
application number: M017
Dermarest Eczema MedicatedHYDROCORTISONEInsight Pharmaceuticals LLC0292ab62-5088-45fa-a056-70c2fcc19ef72024-10-25WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEMeijer, Inc.2db7bcab-acb8-48ad-8cd1-842ff7765ed92024-10-23WarningsExact identifier
application number: M017
NATUREANCE MIRACLEMENTHOLEROS GLOBAL CORPec1a2a1f-a38d-9c59-e053-2a95a90ad2682024-10-23WarningsExact identifier
application number: M017
Profoot Plantar Relief StripsCAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.65e142d8-da21-4c55-9faf-b387cb6c2c0e2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.cc011b79-2761-40f7-8142-88f8e30a179a2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEProfoot, Inc.06f82bde-41a1-35f6-e063-6394a90a64372024-10-23WarningsExact identifier
application number: M017
Deep Cover Bug Bite ReliefBENZOCAINEMorrisons Outdoors, LLC25010dd6-fb48-8ee7-e063-6394a90aee6c2024-10-21WarningsExact identifier
application number: M017
Evel Knievels Natural Choice Pain ReliefMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.4576656c-4b6e-6965-7665-6c52756c65732024-10-21WarningsExact identifier
application number: M017
berkley and jensen anti itchHYDROCORTISONEBJWC5cc6e4f6-c62d-4923-9726-9dbc569a3f492024-10-19WarningsExact identifier
application number: M017
DG Health Hydrocortisone Maximum StrengthHYDROCORTISONEDolgencorp Inc2cc792b8-dce6-4178-bd6d-63ba268b77472024-10-19WarningsExact identifier
application number: M017
Careland Hydrogel Pain Relief PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.e970070c-1c3b-49f0-8298-e6c5ebbf50a02024-10-18WarningsExact identifier
application number: M017
Fruit of the Earth Cool Blue Aloe Mist ContinuousLIDOCAINE HYDROCHLORIDEFruit Of The Earth, Inc.d4caae4c-efba-2453-e053-2995a90a5e5f2024-10-18WarningsExact identifier
application number: M017
CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-RelievingLIDOCAINE HCLCVS Pharmacyf0f1969d-10e0-76ee-e053-2995a90a73362024-10-17WarningsExact identifier
application number: M017
Wong To Yick External AnalgesicCAMPHOR MENTHOL METHYL SALICYLATEWong To Yick Wood Lock Ointment Ltd16a21af4-6bc0-4ae1-aa3b-1da84c8286e22024-10-17WarningsExact identifier
application number: M017
Wong To Yick External AnalgesicCAMPHOR MENTHOL METHYL SALICYLATEWicsun Trading Inc0b4bd444-b3c1-47aa-a7e3-f16c923261242024-10-17WarningsExact identifier
application number: M017
Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCLLIDOCAINEFruit of the Earth, Inc.c7a833bd-7457-73a3-e053-2a95a90ac53f2024-10-17WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72667-101-017266701010150 g in 1 TUBE (72667-101-01) 50 g2025-06-03NoNoCurrent
72667-101-0272667010102177 g in 1 TUBE (72667-101-02) 177 g2025-06-03NoNoCurrent