Tinted Facial Protection SPF40

Product NDC
85630-203
11-digit product format
856300203
Labeler code
85630
Product ID
85630-203_45b3d1cc-b5c0-65f8-e063-6294a90aba22
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
FRESH FACED SKIN CARE LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-29
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 mg/g; mg/g
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
Tinted Facial Protection SPF40
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
35d08e2a-b118-8634-e063-6294a90a918dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85630-203-50Tinted Facial Protection SPF4053 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85630-203TINTED FACIAL PROTECTION SPF40 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FRESH FACED SKIN CARE LLC]1Current NDC, 1 package rows20250524_35d08e2a-b118-8634-e063-6294a90a918d.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 286 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H.E.B Solutions SunscreenKIDS SPF 50 LOTION SPRAYH.E.B9b43c5d5-c279-4ae3-843e-1451f73242162024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenULTRA SPF 50 CONTINUOUS SPRAYH.E.B2e183ba8-1b83-4211-bc08-dbdcee942ce92024-10-15WarningsExact identifier
application number: M020
EQUALINE KIDS SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIe46cb6e3-ea8d-3c2d-e053-2a95a90a0bf62024-10-15WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE SUNSCREENBentley Laboratories LLC782a8641-7e6a-413b-a2ed-0efeb36c48a72024-10-15WarningsExact identifier
application number: M020
H.E.B MANGOSPF 50 SUNSCREENH.E.B35898f07-2973-461a-91b8-095aa4cf38ee2024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenSPORT SPF 30 CONTINUOUS SPRAYH.E.B8b6d0c0d-485b-4428-91e5-5befcac18d5d2024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenULTRA SPF 50 CONTINUOUS SPRAYH.E.B5fd3d730-d916-48f4-bb94-62d40d1812802024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenSPORT SPF 70 CONTINUOUS SPRAYH.E.Bf9b5b360-6b69-4006-934f-5bc8a9fdfcd02024-10-15WarningsExact identifier
application number: M020
HEBGENERAL PROTECTION SPF 100 LOTIONH-E-B39d94e3a-98c8-44b0-bd2d-f318ac7bbf752024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenWET PROTECTION KIDS SPF 70 CONTINUOUS SPRAYH.E.Bf823b236-5884-41d9-bff0-65b91664aaad2024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenCOOLING SPORT SPF 50 CONTINUOUS SPRAYH.E.B67fdf3a0-08fe-4348-a4f9-a83f3cf46b722024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenULTRA SPF 70 CONTINUOUS SPRAYH.E.Bc16935ce-afdb-4571-b5a3-6dc5d01f721c2024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenBABY SPF 50 LOTION SPRAYH.E.B1082111f-bf04-4a98-b6a0-5da933652f1d2024-10-15WarningsExact identifier
application number: M020
H.E.B ULTRASPF 50 SUNSCREENH.E.Bd6184ba2-0e47-459a-8777-1f27be2140a62024-10-15WarningsExact identifier
application number: M020
H.E.B ULTRASPF 30 SUNSCREENH.E.B90287874-cdfa-489c-936d-e487f6b3db962024-10-15WarningsExact identifier
application number: M020
H.E.BSPF 50 SUNSCREENH.E.B2c9258ac-8cbe-4acf-9c02-bb993d69a3e52024-10-15WarningsExact identifier
application number: M020
H.E.BSPF 50 SUNSCREENH.E.B39bf1379-3dee-4aa0-967a-36faccca42162024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenSPORT SPF 100 CONTINUOUS SPRAYH.E.B301ae7e5-5a60-45d0-8cd5-553ba07db4c52024-10-15WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28CHOMOSALATE, ZINC OXIDERare Beauty, LLC2470d78c-724f-4181-e063-6294a90afeaa2024-10-14WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44NHOMOSALATE, ZINC OXIDERare Beauty, LLC2471e0fa-ddc8-1c62-e063-6294a90a44082024-10-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85630-203-508563002035053 g in 1 BOTTLE, PUMP (85630-203-50) 53 g2020-01-29NoNoCurrent