FDA.reportPublic FDA data

Facial Mineral Sunscreen Mineral Protection

Product NDC
85627-201
11-digit product format
856270201
Labeler code
85627
Product ID
85627-201_45b4a595-977d-c1af-e063-6294a90a944a
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
CAPE COD SKIN CARE CO. INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-21
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
38; 80 mg/g; mg/g
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
Facial Mineral Sunscreen Mineral Protection
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
387f6dd5-3901-0849-e063-6294a90af8bcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85627-201-85Facial Mineral Sunscreen Mineral Protection85 g in 1 BOTTLE, PUMPCREAM852

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 245 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.f8361aa8-c3ad-0c47-e053-6394a90a6ab02025-01-01WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.d6807577-56a1-a40c-e053-2995a90a59352025-01-01WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.0289088d-3316-c90c-e063-6294a90a69e02025-01-01WarningsExact identifier
application number: M020
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.a4364c8d-8b74-130e-e053-2995a90ad1c12025-01-01WarningsExact identifier
application number: M020
b.tan Tropic Like Its Hot SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMarque of Brands Americas, LLCbb15b1bc-cfc0-0bab-e053-2a95a90af5b32025-01-01WarningsExact identifier
application number: M020
Obagi Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMDTITANIUM DIOXIDE AND ZINC OXIDEObagi Cosmeceuticals LLCff95a7b7-3cb4-41b0-866d-69361354a0bc2025-01-01WarningsExact identifier
application number: M020
Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30 SUNSCREENAVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONEObagi Cosmeceuticals LLC84f0f1dd-13f2-49f5-89b3-fab175ac25642025-01-01WarningsExact identifier
application number: M020
NU-DERM HEALTHY SKIN PROTECTION SPF 35OCTINOXATE AND ZINC OXIDEObagi Cosmeceuticals LLCcfb6a918-1403-4cf2-86d8-d66dd764bb6c2025-01-01WarningsExact identifier
application number: M020
CLARINS Super Restorative Day Illuminating lifting replenishing BROAD SPECTRUM - SPF 20 - SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENELaboratoires Clarinsc6dffe5c-5539-4e86-bf5e-b0e497eb9c882024-12-31WarningsExact identifier
application number: M020
Badger Adventure Sport Clear Mineral Sunscreen SPF 50ZINC OXIDEW.S. Badger Company, Inc.d10290b4-3c8a-e0bb-e053-2995a90a9b6b2024-12-31WarningsExact identifier
application number: M020
Badger BROAD SPECTRUM SPF 15 Lip BalmZINC OXIDEW.S. Badger Company, Inc.d506ac39-5019-1291-e053-2995a90a796a2024-12-31WarningsExact identifier
application number: M020
Badger Kids Mineral Sunscreen Cream Broad Spectrum SPF 40ZINC OXIDEW.S. Badger Company, Inc.d619d2b4-bae8-bc76-e053-2995a90a369b2024-12-31WarningsExact identifier
application number: M020
Badger SPF 35 Kids Clear Face StickZINC OXIDEW.S. Badger Company, Inc.d1038442-ec86-07e3-e053-2995a90ad6ab2024-12-31WarningsExact identifier
application number: M020
Badger Baby Sunscreen Cream Broad Spectrum SPF 40ZINC OXIDEW.S. Badger Company, Inc.d61acaa0-73ef-eccf-e053-2995a90ad9402024-12-31WarningsExact identifier
application number: M020
Badger Broad Spectrum SPF 35 Active Face StickZINC OXIDEW.S. Badger Company, Inc.d61b0dc8-3864-d5e3-e053-2a95a90ac02f2024-12-31WarningsExact identifier
application number: M020
Badger Active SPF 30 Mineral SunscreenZINC OXIDEW.S. Badger Company, Inc.e169289b-811c-6033-e053-2a95a90a6f2a2024-12-31WarningsExact identifier
application number: M020
Badger Sport Mineral Sunscreen Cream Broad Spectrum SPF 40ZINC OXIDEW.S. Badger Company, Inc.d60b1145-7c3e-3668-e053-2a95a90a23742024-12-31WarningsExact identifier
application number: M020
Badger Sport Clear Mineral Sunscreen SPF 40ZINC OXIDEW.S. Badger Company, Inc.d5049a21-12c1-2efb-e053-2a95a90a25922024-12-31WarningsExact identifier
application number: M020
Almay Healthy Biome Makeup GoldenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a94c0a2-8a4c-39b9-e063-6394a90acf8c2024-12-31WarningsExact identifier
application number: M020
Almay Healthy Biome Makeup LightHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a948e37-0554-d953-e063-6394a90a75e62024-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85627-201-858562702018585 g in 1 BOTTLE, PUMP (85627-201-85) 85 g2023-04-21NoNoCurrent