FDA.reportPublic FDA data

FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 15 SUNSCREEN HAND

Product NDC
71499-103
11-digit product format
714990103
Labeler code
71499
Product ID
71499-103_4008f1f0-7b0f-eaf6-e063-6294a90a14d5
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
KENDO HOLDINGS INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-12
Substance
ZINC OXIDE
Active strength
11 g/100mL
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
FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 15 SUNSCREEN HAND
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE11 g/100mL

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
f92b75bd-c5b7-0320-e053-6394a90ab4c3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71499-103-01FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 15 SUNSCREEN HAND1 in 1 BOXCREAM13
71499-103-01FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 15 SUNSCREEN HAND40 mL in 1 TUBECREAM403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71499-103FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 15 SUNSCREEN HAND (ZINC OXIDE) CREAM [KENDO HOLDINGS INC]2Current NDC, 2 package rows20240108_f92b75bd-c5b7-0320-e053-6394a90ab4c3.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 259 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum Medicated Lip Balm OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Companyf84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df12024-12-17WarningsExact identifier
application number: M020
Mentholatum Natural Ice Sport SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company57c35631-42d3-4c6c-bcbb-e2de92b45b132024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMary Kay Inc.5f09503e-c455-4ac2-8d07-e8e66c2daa322024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to MediumHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.b5ca4bed-4f89-4020-a055-9d11f4cd50582024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.e5fffd20-1d22-485a-9311-4cb4f9264f6f2024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.404990e4-9499-4186-b39d-afc31834d3342024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.6028e210-a8a3-4d84-a462-16a414c310522024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very LightHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.af22b3a5-ac72-4c2a-aa7e-6b5ca07d89e82024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30AVOBENZONE/OCTISALATE/OCTOCRYLENEMary Kay Inc.00f0f30d-236a-fd45-e063-6294a90a747d2024-12-17WarningsExact identifier
application number: M020
Softlips Cherry Cordial, Maple Butter, Frosted BerryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybab8447b-58b8-4160-a91e-05f9fd09ed1d2024-12-17WarningsExact identifier
application number: M020
STUDIO FIX FLUID BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEMAKEUP ART COSMETICSfb59afc1-1dc9-f783-e053-6394a90a196b2024-12-17WarningsExact identifier
application number: M020
Mary Kay Mineral Facial Sunscreen Broad Spectrum SPF30ZINC OXIDEMary Kay Inc.0e9b15e4-e59c-f266-e063-6394a90ab81c2024-12-17WarningsExact identifier
application number: M020
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREENOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEMAKEUP ART COSMETICSe5fd3e40-de1d-4cdd-b725-4a517514ca352024-12-17WarningsExact identifier
application number: M020
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35OCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICS2d034810-7210-4ad4-be23-ec2100f8c2f12024-12-17WarningsExact identifier
application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NVacda1640-0d35-43dc-8734-d47b00cc85ed2024-12-17WarningsExact identifier
application number: M020
Mary Kay Foundation PrimerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMary Kay Inc.59d25b44-1adb-4790-8ce6-2d847a06b8b32024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm The Go SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMary Kay Inc.cf7fb8f0-483d-443b-b381-086a255f07832024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm Sampler SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMary Kay Inc.0a9ee359-19c1-4266-8a51-a68f655de1512024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMary Kay Inc.d459e2f7-dc78-4519-9733-01495fc447a22024-12-17WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Tinted Mineral Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.2982ce67-f136-b93b-e063-6394a90a81ac2024-12-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71499-103-01714990103011 TUBE in 1 BOX (71499-103-01) / 40 mL in 1 TUBE1 tube2023-04-12NoNoCurrent