FDA.reportPublic FDA data

Well People Bio Tint SPF 30 Sunscreen 13w

Product NDC
76354-478
11-digit product format
763540478
Labeler code
76354
Product ID
76354-478_4309d3da-cfee-9bd8-e063-6394a90a475c
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
e.l.f. Cosmetics, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-01
Substance
ZINC OXIDE
Active strength
200 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Well People Bio Tint SPF 30 Sunscreen 13w
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 mg/mL

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
c8a9bf6c-80cd-5884-e053-2a95a90a4a66Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76354-478-01Well People Bio Tint SPF 30 Sunscreen 13w35.5 mL in 1 BOTTLECREAM35.55
76354-478-01Well People Bio Tint SPF 30 Sunscreen 13w1 in 1 BOXCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76354-478WELL PEOPLE BIO TINT SPF 30 SUNSCREEN 13W (ZINC OXIDE) CREAM [E.L.F. COSMETICS, INC]4Current NDC, Legacy NDC, 2 package rows20241208_c8a9bf6c-80cd-5884-e053-2a95a90a4a66.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 144 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-Tinted Foaming Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE AESTHETICS ACADEMY, LLC3698c076-68b1-7d28-e063-6394a90a517c2025-12-09Exact identifier
application number: M020
Non-Tinted Replenishing Daily ProtectionZINC OXIDETHE AESTHETICS ACADEMY, LLC3699159a-3561-9ff6-e063-6394a90af9fd2025-12-09Exact identifier
application number: M020
Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325c1723-fb1d-ae3c-e063-6294a90a46092025-12-09Exact identifier
application number: M020
Sheer Mineral Sunscreen Satin Dewy FinishZINC OXIDETRU SKIN RITUALS3249d05b-0f5c-4787-e063-6294a90aa0d72025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325c3a18-ba8f-912d-e063-6394a90a24472025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325c8641-1161-b8ac-e063-6394a90ae4512025-12-09Exact identifier
application number: M020
Sheer Mineral Sunscreen Silk Matte FinishTITANIUM DIOXIDE, ZINC OXIDETRU SKIN RITUALS3248eb22-1e10-2091-e063-6394a90ad3e12025-12-09Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325cce54-a885-d586-e063-6394a90a90db2025-12-09Exact identifier
application number: M020
Sheer Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDETRU SKIN RITUALS324acd75-9c38-4adc-e063-6394a90afa122025-12-09Exact identifier
application number: M020
Sheer Mineral Sunscreen Satin Dewy FinishZINC OXIDETRU SKIN RITUALS324960e6-c1e7-d2b9-e063-6294a90a92ce2025-12-09Exact identifier
application number: M020
Sol Purpose Mineral Sunscreen TintedZINC OXIDETRU SKIN RITUALS324a3475-07f0-033c-e063-6394a90a811a2025-12-09Exact identifier
application number: M020
Perfect Sunscreen SPF 50 Sheer MineralZINC OXIDEBluemercury, Inc.d8f483ff-b990-40c5-b5b8-00065051ae7e2025-12-09WarningsExact identifier
application number: M020
Foto Facial Age Delay Non-TintedTITANIUM DIOXIDE ZINC OXIDEADVANCED AESTHETIC DERMATOLOGY42674013-fa2b-42d7-e063-6294a90af9992025-12-09WarningsExact identifier
application number: M020
Hydraboost Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBluemercuryeca867e6-4deb-4be2-ae3f-6850fb6223b32025-12-09WarningsExact identifier
application number: M020
Foto Facial Age Delay Matte TintedTITANIUM DIOXIDE ZINC OXIDEADVANCED AESTHETIC DERMATOLOGY42761919-8ae2-3c41-e063-6394a90abb8f2025-12-09WarningsExact identifier
application number: M020
Dew MineralZINC OXIDEADVANCED AESTHETIC DERMATOLOGY42f17245-92a9-3915-e063-6394a90a68172025-12-09WarningsExact identifier
application number: M020
Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEYUMA ACNE CLINIC, L.L.C.3c69b707-07ff-1a82-e063-6394a90a9fcd2025-12-09WarningsExact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEYUMA ACNE CLINIC, L.L.C.3c69f93f-0385-365c-e063-6394a90a12fd2025-12-09WarningsExact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDEYUMA ACNE CLINIC, L.L.C.3c6a5601-a7a2-5e20-e063-6394a90a66432025-12-09WarningsExact identifier
application number: M020
Bronzing Blendrops Broad Spectrum SPF 40HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC124ca946-8412-4d6d-e063-6294a90a63382025-12-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76354-478-01763540478011 BOTTLE in 1 BOX (76354-478-01) / 35.5 mL in 1 BOTTLE1 bottle2021-09-010000-00-00NoNoCurrent