FDA.reportPublic FDA data

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 186 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
I.C. Industrial SunscreenZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATER & R Lotion, Incb89d687a-7b36-4643-9817-765d4710ca602025-09-15WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC97795f0e-d867-4e17-b7c9-ede08e7df70c2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 36N DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.2d05659c-57d2-4faf-ab67-1b8d68945aed2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 37W DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.5ff2b9e4-a778-4667-8c3c-3561317b374a2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 39N DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.bc4f909f-3e2c-4fd7-a129-3c2fac8259f02025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 40C DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.2dd9a30a-2cde-44c0-9350-3aeab9f7091b2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Get Your Healthy Glowy Skin Bergamot Glow Primer Blueberry Nutri TintZINC OXIDEDolce & Gabbana Beauty S.R.Le375412e-8685-49a2-b1b0-00ab114e14b72025-09-12WarningsExact identifier
application number: M020
Beach Club Mineral SunscreenZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATER & R Lotion, Incd9aae241-229e-4123-abe9-99f74f5ab0b32025-09-12WarningsExact identifier
application number: M020
sunscreenTITANIUM DIOXIDE(NANO)Mingyu (guangdong) Cosmetics Technology Co., Ltd3e6fe9f3-486b-bba7-e063-6294a90adf372025-09-10WarningsExact identifier
application number: M020
Zinc Oxide Titanium OxideZINC OXIDE TITANIUM OXIDEHello Bello3e66c234-a152-098e-e063-6394a90ab5402025-09-10WarningsExact identifier
application number: M020
Basin Sun Stick SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.3e78026e-0a6a-9e67-e063-6294a90a1bca2025-09-10WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 30N Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.428dac83-37dc-4b54-82e9-664f59f9af332025-09-10WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 31N Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.3174b962-12c0-43b4-8a9c-56fb044afd662025-09-10WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 34W DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.c4135505-f0c5-4a91-91e2-ca0e38a0136c2025-09-10WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 35W DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.c5f65d27-4ad8-4188-98aa-0d9c2dd361802025-09-10WarningsExact identifier
application number: M020
Zinc Oxide Titanium OxideZINC OXIDE TITANIUM OXIDEHello Bello3e89d30e-b6cd-fabe-e063-6294a90a30ff2025-09-10WarningsExact identifier
application number: M020
Ocean Potion Suncare 30 Continuous Sunscreen Scent of SunshineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3e60bd44-1984-57c6-e063-6294a90a1f4e2025-09-09WarningsExact identifier
application number: M020
Ocean Potion Suncare 70 Continuous Sunscreen Scent of SunshineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3e60d362-4700-1042-e063-6394a90ab39f2025-09-09WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 25W Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.3d2a702b-2ff6-473a-9ab1-823e0e53a8cf2025-09-09WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 29W Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.285c9b63-ae65-4508-8bba-1541b3cc43802025-09-09WarningsExact 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