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 4 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Round Lab Holiday Heroes Gift SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.5a0d3a85-caff-a90d-e063-6394a90ad0452026-08-27WarningsExact identifier
application number: M020
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
application number: M020
Hero Force Shield Superlight Sunscreen SPF 30ZINC OXIDEChurch & Dwight Co., Inc.140268a9-adb9-4574-ad82-4a2e924dc8082026-08-26WarningsExact identifier
application number: M020
Juyasuyon Sport Ultra Sunscreen CreamOCTOCRYLENE,OXYBENZONE,AVOBENZONE,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEGuangdong Aimu Biological Technology Co., Ltd598cfe9e-6ebe-ad18-e063-6294a90ace222026-08-25WarningsExact identifier
application number: M020
NeoStrata Sheer Hydration Sunscreen Broad Spectrum SPF 40OCTINOXATE, OCTISALATE, AND AVOBENZONENeoStrata Company Inc.e8cdf9f7-d968-42b3-bcb8-02dee7717fd82026-08-25WarningsExact identifier
application number: M020
JUYASUYON Sport Ultra SunscreenAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGuangdong Aimu Biological Technology Co., Ltd59d97ee0-e416-53e7-e063-6294a90a91532026-08-25WarningsExact identifier
application number: M020
NeoStrata Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35OCTINOXATE, OCTISALATE, AND AVOBENZONENeoStrata Company Inc.ed495f18-2f8e-4991-b797-82e9f6fc7acb2026-08-25WarningsExact identifier
application number: M020
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.59e9279a-2427-d6bc-e063-6394a90ae86e2026-08-25WarningsExact identifier
application number: M020
Exuviance Age Reverse Day Repair with Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.4739e678-ce51-4863-bb74-2275879e1b472026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(YELLOW)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c3009b-ae16-52e1-e063-6394a90a69ee2026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(PINK)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c68d9b-9aa9-4996-e063-6394a90a48d42026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(BLUE)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c78929-9df7-5212-e063-6394a90a37662026-08-24WarningsExact identifier
application number: M020
Dr Marvel COLOR CHANGING FOUNDATION SPF30ETHYLHEXYL METHOXYCINNAMATEGuangzhou Liyan Cosmetics Technology Co., Ltd.59c8865f-ccee-dd50-e063-6294a90aa1852026-08-24WarningsExact identifier
application number: M020
Exuviance Daily Corrector with Sunsreen Broad Spectrum SPF 35OCTINOXATE, OCTISALATE, AND AVOBENZONENeoStrata Company Inc.74a998e2-8ebf-436c-aac1-b456cd2e072d2026-08-24WarningsExact identifier
application number: M020
Homosalate, Octisalate, Zinc oxideHOMOSALATE, OCTISALATE, ZINC OXIDEAldi Inc59cbfb14-d9b1-ce93-e063-6394a90ac3122026-08-24Warnings, Adverse reactionsExact identifier
application number: M020
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.59ac747a-f9c7-2c18-e063-6394a90a23062026-08-23WarningsExact identifier
application number: M020
Sunski Sol Power Daily Face Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLCb6c3d6b1-3d8a-43c0-aac5-07fe60afbd8c2026-08-21WarningsExact 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