FDA.reportPublic FDA data

Matte Defense Mineral Sunscreen non tinted

Product NDC
85367-202
11-digit product format
853670202
Labeler code
85367
Product ID
85367-202_4614ce9a-072f-098c-e063-6294a90a2f6b
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
PURE VITALITY SKIN AND BODY, INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-02
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
Matte Defense Mineral Sunscreen non tinted
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
3698090a-1639-00f9-e063-6394a90a7dd1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85367-202-50Matte Defense Mineral Sunscreen non tinted53 g in 1 BOTTLE, PUMPCREAM532

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 198 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1dd9fe59-9e40-fd06-e063-6394a90a4ca22025-08-12WarningsExact identifier
application number: M020
Coola Anti-Aging Hand Cream SunscreenAVOBENZONE, OCTOCRYLENE, OCTISALATECOOLA LLC3c2fbf10-d68e-c601-e063-6294a90a09a32025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 15mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD24ea340a-06cd-b085-e063-6394a90adff92025-08-12WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.15536331-fec5-4daa-824d-2e32d63e64522025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1ddad045-7703-ea7e-e063-6394a90a2a5a2025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 15mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD0cf45fbf-b257-f16a-e063-6294a90a87942025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 40mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1ddb1f53-69dd-643a-e063-6394a90ad6002025-08-12WarningsExact identifier
application number: M020
Earth Mama Lady Face Mineral Sunscreen - Medium/Dark Tint Broad Spectrum SPF 40ZINC OXIDEEarth Mama Angel Baby LLC908c41fd-0496-4237-813b-1135e10ae0c52025-08-12WarningsExact identifier
application number: M020
Earth Mama Baby Mineral Sunscreen SPF 40ZINC OXIDEEarth Mama Angel Baby, LLC74475fba-4cdd-4b27-8ea4-646f4016580c2025-08-12WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 25ZINC OXIDEEarth Mama Angel Baby, LLC2aa44439-663a-400b-b432-e2dc5ac2a3d12025-08-12WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 40ZINC OXIDEEarth Mama Angel Baby, LLCafc88e77-a4a1-49ec-b021-bb468fd0ac682025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD31049b45-0f5e-58b6-e063-6394a90ae52c2025-08-12WarningsExact identifier
application number: M020
Earth Mama Lady Face Mineral Sunscreen - Light/Medium Tint Broad Spectrum SPF 40ZINC OXIDEEarth Mama Angel Baby LLCbd71a814-c0b4-428b-987e-72f7f55f998f2025-08-12WarningsExact identifier
application number: M020
earth mama UBER-SENSITIVE MINERAL Sunscreen SPF 40ZINC OXIDEEarth Mama Angel Baby, LLCe9a88a57-5733-489d-a459-dd74c04daff22025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1ddae545-99db-144b-e063-6294a90adae52025-08-12WarningsExact identifier
application number: M020
Sun Bum Protecting Scalp and Hair Mist SPF 30 sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3aa05afb-c843-f38f-e063-6294a90a1cdf2025-08-12WarningsExact identifier
application number: M020
Sun Bum High Performance Sunscreen Signature Clear 50OCTOCRYLENE, OCTISALATE, ZINC OXIDESun Bum, LLC390c6afd-e2be-414c-e063-6294a90ae1192025-08-12WarningsExact identifier
application number: M020
Sun Bum 30 Premium Mosturizing Sunscreen 1 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c32d2c0-0dbe-42e3-e063-6294a90aa9932025-08-12WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c342e57-cf85-b423-e063-6394a90a61b92025-08-12WarningsExact identifier
application number: M020
MATTE UNIVERSAL TINTED MOISTURIZER SPF46ZINC OXIDE, OCTINOXATEDrmtlgy, LLC8e284afd-b90f-41d5-b334-e5cf4440b4d32025-08-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85367-202-508536702025053 g in 1 BOTTLE, PUMP (85367-202-50) 53 g2022-11-02NoNoCurrent