FDA.reportPublic FDA data

Prime Protection Sunscreen non tinted

Product NDC
85641-202
11-digit product format
856410202
Labeler code
85641
Product ID
85641-202_45c7395f-5c91-d388-e063-6294a90a1e29
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
KRISTI REDD ESTHETICS
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-21
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
Prime Protection 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
36608832-22d8-bc76-e063-6394a90abac6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85641-202-50Prime Protection 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 126 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Skin Shield PlusZINC OXIDELAURA CATHERINE, LLC36e9958b-cc5c-f7ff-e063-6394a90ac80d2025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen Plus Primer MatteTITANIUM DIOXIDE, ZINC OXIDESimply Bare Waxing & Skin Care LLC36d8e8ba-a3dd-257d-e063-6294a90a30d62025-12-15Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e9e8d7-3fcf-1e94-e063-6394a90a8dc62025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen Plus Primer CPlusE GlowZINC OXIDESimply Bare Waxing & Skin Care LLC36d968df-5168-61bf-e063-6294a90a94b72025-12-15Exact identifier
application number: M020
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN STUDIO36d45b48-e08d-ef40-e063-6394a90a635c2025-12-15Exact identifier
application number: M020
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN STUDIO36d439fb-b9cf-2774-e063-6294a90ae8852025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen Plus Primer CPlusE GlowZINC OXIDESimply Bare Waxing & Skin Care LLC36d9b48d-e3db-6ae2-e063-6294a90abbf52025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen Plus Primer MatteTITANIUM DIOXIDE, ZINC OXIDESimply Bare Waxing & Skin Care LLC36d9d83b-7da7-a006-e063-6394a90a9d842025-12-15Exact identifier
application number: M020
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN & ACNE36d3ebc0-1de6-1998-e063-6294a90a02e62025-12-15Exact identifier
application number: M020
Sun Safe Lip BalmTITANIUM DIOXIDE, ZINC OXIDEREVIVE IN SOLANO36c4f0c9-5789-ca58-e063-6394a90a23232025-12-15Exact identifier
application number: M020
Titanium Dioxide, Zinc OxideON THE GO SUNSCREEN STICKREVIVE IN SOLANO36c57e6f-c747-9926-e063-6294a90a57212025-12-15Exact identifier
application number: M020
Daily Shade Dewy Glow TintedZINC OXIDEBLISS BEAUTY LLC373babab-2949-5474-e063-6394a90aacd72025-12-15Exact identifier
application number: M020
Daily Shade Matte TintedTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC3739bdb8-2152-b2ba-e063-6294a90acd942025-12-15Exact identifier
application number: M020
Daily Shade Matte TintedTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC37396a51-225d-7669-e063-6294a90af6d32025-12-15Exact identifier
application number: M020
Daily Shade Dewy Glow TintedZINC OXIDEBLISS BEAUTY LLC373a4c37-e280-bacb-e063-6394a90a5af82025-12-15Exact identifier
application number: M020
Daily Shade Sheer MatteZINC OXIDEBLISS BEAUTY LLC373a0d67-b225-ecb0-e063-6294a90a9ac12025-12-15Exact identifier
application number: M020
Daily Shade Sheer MatteZINC OXIDEBLISS BEAUTY LLC373b3e56-f923-dd24-e063-6294a90acf532025-12-15Exact identifier
application number: M020
Tinted Lip Shade SunscreenTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC373a7c01-ba9f-4b00-e063-6294a90ae1a22025-12-15Exact identifier
application number: M020
Daily Shade Matte TintedTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC373b7ab9-c692-fc1b-e063-6294a90aa8032025-12-15Exact identifier
application number: M020
Antioxidant Mineral Sunscreen Plus Primer Lightly TintedZINC OXIDETrue Beauty Brows & Skin Care37dc4599-bd97-8c85-e063-6294a90ad1dc2025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85641-202-508564102025053 g in 1 BOTTLE, PUMP (85641-202-50) 53 g2021-04-21NoNoCurrent