SPF 50 Mineral Sunscreen Face and Body

Product NDC
85865-002
11-digit product format
858650002
Labeler code
85865
Product ID
85865-002_52cc5adc-9233-e0ff-e063-6394a90a227e
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Toddle Born Wild, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-10
Substance
ZINC OXIDE
Active strength
20 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 Face and Body
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 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
e97d82fe-cd45-43a5-9c1f-3900025240a1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85865-002-01SPF 50 Mineral Sunscreen Face and Body50 mL in 1 TUBELOTION503
85865-002-02SPF 50 Mineral Sunscreen Face and Body100 mL in 1 TUBELOTION1003
85865-002-03SPF 50 Mineral Sunscreen Face and Body177 mL in 1 PACKAGELOTION1773

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 12 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Juice Body Mist Sunscreen SPF30 - Cotton Candy Skies PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC568083ff-0da9-7f14-e063-6394a90a43012026-07-13WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Vanilla Breeze PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc62c97-70c5-17f7-e063-6394a90abe252026-07-13WarningsExact identifier
application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 RoseZINC OXIDENorwex Usa, Inc.565feded-8e25-e628-e063-6294a90aee482026-07-11WarningsExact identifier
application number: M020
PoutScreen Lip Treatment Lemon MeringueAVOBENZONE, OCTINOXATE, OCTOCRYLENENAKED SUNDAYS PTY LTD563e3ab9-4ee2-279c-e063-6294a90a7cf12026-07-10WarningsExact identifier
application number: M020
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWNZINC OXIDECOSMAX USA, CORPORATION5643a73d-757c-702d-e063-6294a90a2c122026-07-10WarningsExact identifier
application number: M020
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - LATTEZINC OXIDECOSMAX USA, CORPORATION5643d655-e335-5643-e063-6394a90a483a2026-07-10WarningsExact identifier
application number: M020
MUSELY DAYCREAM SPF40ZINC OXIDECOSMAX USA, CORPORATION56443156-3edb-a643-e063-6394a90adf9f2026-07-10WarningsExact identifier
application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40ZINC OXIDECosmax USA, Corporation56445f2d-8e5a-34eb-e063-6294a90ae26e2026-07-10WarningsExact identifier
application number: M020
Hello Kitty Fun Broad Spectrum SPF 40ZINC OXIDECosmax USA Corporation5644854e-18d6-617d-e063-6294a90ab3e72026-07-10WarningsExact identifier
application number: M020
VERSED DAILY SUNSCREEN SPF 50HOMOSALATE, OCTISALATE, AVOBENZONECOSMAX USA, CORP5644ca1e-9032-d3fb-e063-6394a90a961e2026-07-10WarningsExact identifier
application number: M020
Hello Kitty Sunny Days Broad Spectrum SPF 40ZINC OXIDECosmax USA Corporation5644855d-f864-e07b-e063-6394a90a51482026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40ZINC OXIDECOSMAX USA, CORP5644d49f-08b9-e806-e063-6294a90a80f92026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT NEUTRALZINC OXIDECOSMAX USA, CORP564682e5-1051-9936-e063-6394a90abe1d2026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT WRMZINC OXIDECOSMAX USA, CORP5646e069-5461-12c5-e063-6294a90abacb2026-07-10WarningsExact identifier
application number: M020
Protect Sport SunscreenBROAD SPECTRUM SPF 30Opal Day Spa564704f2-b26a-d737-e063-6294a90aa6ff2026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM NEUTRALZINC OXIDECOSMAX USA, CORP5647162a-610e-2789-e063-6294a90a75492026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM OLIVEZINC OXIDECOSMAX USA, CORP56472adb-572d-5a52-e063-6294a90a3cc32026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM COOLZINC OXIDECOSMAX USA, CORP56474782-beff-8437-e063-6294a90a83222026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM PEACHZINC OXIDECOSMAX USA, CORP564749f3-e820-9003-e063-6294a90a02652026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN NEUTRALZINC OXIDECOSMAX USA, CORP56477f58-3878-81fa-e063-6294a90a87b72026-07-10WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85865-002-018586500020150 mL in 1 TUBE (85865-002-01) 50 ml2025-12-10NoNoCurrent
85865-002-0285865000202100 mL in 1 TUBE (85865-002-02) 100 ml2026-02-10NoNoCurrent
85865-002-0385865000203177 mL in 1 PACKAGE (85865-002-03) 177 ml2025-12-10NoNoCurrent