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 220 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Superactive Moisturizer SPF 50 Brightening SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC4ff8525a-4526-4acf-86c7-88f1f10732742025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 UnflavoredLIP BALM SPF15LS Promotions Inc3131632d-735c-6688-e063-6294a90a02392025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Chocolate Sundae flavoredLIP BALM SPF15LS Promotions Inc3142f352-ee65-47b5-e063-6394a90ada572025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Pina Colada flavoredLIP BALM SPF15 PINA COLADA FLAVOREDLS Promotions Inc31440153-e7ca-1327-e063-6294a90a562c2025-03-26WarningsExact identifier
application number: M020
CVS Health Sport 100 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACY0a245b1b-eaf6-7011-e063-6294a90ab68f2025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Apple Pie flavoredLIP BALM SPF15 APPLE PIE FLAVOREDLS Promotions Inc3145bd6d-0ece-e9d5-e063-6294a90afb9d2025-03-26WarningsExact identifier
application number: M020
HEB Glow 40 Tinted Sunscreen Face PrimerAVOBENZONE, OCTISALATE, OCTOCRYLENEH.E.B.3146bcd9-d562-9ba6-e063-6294a90a37aa2025-03-26WarningsExact identifier
application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide SunscreenZINC OXIDEH.E.B.3146fb5f-1fb5-f09f-e063-6294a90a62062025-03-26WarningsExact identifier
application number: M020
HEB 50 Glow Body Oil SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.31473cc9-08f5-39e3-e063-6294a90aa4992025-03-26WarningsExact identifier
application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide SunscreenZINC OXIDEH.E.B.314776a8-a562-3dd2-e063-6394a90ab1b92025-03-26WarningsExact identifier
application number: M020
TRADER JOES INVISIBLE BODY SUNSCREEN SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company31478f5a-88f4-4b01-e063-6394a90a04b72025-03-26WarningsExact identifier
application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company3147c08f-c3f2-aef1-e063-6294a90a5c442025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Mangonada Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B3147ef18-9029-6d5b-e063-6394a90acee02025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Mexican Vanilla Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B31487bad-a756-9050-e063-6394a90acacc2025-03-26WarningsExact identifier
application number: M020
TRADER JOES DAILY FACIAL MINERAL SUNSCREEN SPF 40ZINC OXIDETrader Joe's Company3148c00f-21bb-c05f-e063-6394a90af0e82025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Chamomile and Lavender Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B314b8147-fe7a-0698-e063-6394a90a872c2025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Shine Sunscreen with Vitamin C Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B314bcf42-ca01-0fa5-e063-6294a90a5fc82025-03-26WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Hydrating SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC1e5d494b-dccf-4ba1-89de-0bb4ba5b8d382025-03-26WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Wrinkle Fighting SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEMurad, LLCac6163fb-dbc1-432f-a590-86d31c93b29b2025-03-26WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral MediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe17dc640-30e9-441b-a212-ef1508af79442025-03-25WarningsExact 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