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 129 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Canopy UntintedZINC OXIDEBORREGO SPRINGS SKINCARE LLC35824cd5-0036-7886-e063-6394a90ae6782025-12-12Exact identifier
application number: M020
Canopy SPF 40 TintedZINC OXIDEBORREGO SPRINGS SKINCARE LLC358319c5-ae35-cb3b-e063-6394a90ad77f2025-12-12Exact identifier
application number: M020
Non-Tinted Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581ab49-ef55-3743-e063-6394a90a3bd52025-12-12Exact identifier
application number: M020
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581cf33-3520-42f7-e063-6394a90a6f932025-12-12Exact identifier
application number: M020
Mineral Sunscreen For Face and BodyZINC OXIDESkin Philosophy by Kelly358248e6-16cf-6f9b-e063-6394a90a55d72025-12-12Exact identifier
application number: M020
Replenishing Mineral SunscreenZINC OXIDESkin Philosophy by Kelly35828e76-66db-49de-e063-6294a90a2b992025-12-12Exact identifier
application number: M020
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3592b2c7-295a-7c60-e063-6394a90a387b2025-12-12Exact identifier
application number: M020
Mineral Sunscreen For Face and BodyZINC OXIDESkin Philosophy by Kelly3592fd5f-13d1-9aec-e063-6394a90abd672025-12-12Exact identifier
application number: M020
Replenishing Mineral SunscreenZINC OXIDESkin Philosophy by Kelly359371f2-2407-e1a1-e063-6294a90a21652025-12-12Exact identifier
application number: M020
Non Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC397fc3c9-9d30-adcf-e063-6394a90ac7612025-12-12Exact identifier
application number: M020
Non Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC39800bf1-e01a-e1c8-e063-6294a90a53bf2025-12-12Exact identifier
application number: M020
Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC397130ea-dfad-ecd3-e063-6394a90a7da42025-12-12Exact identifier
application number: M020
Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC39716532-a699-63b7-e063-6294a90aa0f02025-12-12Exact identifier
application number: M020
Sun Elegant Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDESKIN BY NESRIN3580ae10-1867-cb68-e063-6394a90a72df2025-12-12Exact identifier
application number: M020
Simply Zinc Mineral Sunscreen TintedZINC OXIDESKIN BY NESRIN3580da4f-116d-8108-e063-6294a90a7bf42025-12-12Exact identifier
application number: M020
PROTECTOR SOLAR NON-TINTED SPF SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEThe Beez Kneez Skin Care & Acne Clinic LLC358195c0-6d28-1ffe-e063-6394a90a60272025-12-12Exact identifier
application number: M020
PROTECTOR SOLAR TINTED SPF SUNSCREENZINC OXIDEThe Beez Kneez Skin Care & Acne Clinic LLC3581d973-ac0b-7d2e-e063-6294a90ae2b32025-12-12Exact identifier
application number: M020
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation3583f860-664b-2658-e063-6394a90a38572025-12-12Exact identifier
application number: M020
Satin TintZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation35920108-7f8a-27d4-e063-6294a90a0ef62025-12-12Exact identifier
application number: M020
SPF LipTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359297cd-10e2-6ddd-e063-6394a90a4aa02025-12-12Exact 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