FDA.reportPublic FDA data

Advanced Sun Protection

Product NDC
85609-203
11-digit product format
856090203
Labeler code
85609
Product ID
85609-203_46052dc8-4da8-4b76-e063-6394a90a2f9e
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
HELLO BEAUTIFUL SKIN STUDIO
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-12
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 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
Advanced Sun Protection
Listing expiration
2026-12-31

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
36d45b48-e08d-ef40-e063-6394a90a635cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85609-203-15Advanced Sun Protection1.5 g in 1 BOTTLE, PUMPCREAM1.52
85609-203-50Advanced Sun Protection53 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 145 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfecting Blendrops Broad Spectrum SPF 40HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC12512cac-652e-b138-e063-6394a90ad1f22025-12-09WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEASHLEY SAMAI38f457fa-0e95-7298-e063-6394a90adda82025-12-09Exact identifier
application number: M020
Non-Tinted Mineral SunscreenZINC OXIDEOLGA KLIMOV INC387b41a4-057f-88af-e063-6394a90adbbe2025-12-09Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDEOLGA KLIMOV INC387b8ae6-c48b-905c-e063-6394a90a31fb2025-12-09Exact identifier
application number: M020
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS36ea709b-3536-5052-e063-6394a90a48f92025-12-09Exact identifier
application number: M020
Age Defying Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDEMARK SCHWARTZ CLINICAL SKINCARE, INC.3b028159-f240-2cf2-e063-6294a90a32b52025-12-09WarningsExact identifier
application number: M020
Ultimate Mineral ProtectionZINC OXIDEMARK SCHWARTZ CLINICAL SKINCARE, INC.3b02bf69-b648-56e1-e063-6294a90aeef32025-12-09WarningsExact identifier
application number: M020
G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREENZINC OXIDE, TITANIUM DIOXIDELABORATOIRES DERMO-COSMETIK INC.01dcfd14-7a1d-98fa-e063-6294a90a03362025-12-09WarningsExact identifier
application number: M020
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS3aff2074-1514-b5c5-e063-6394a90a75722025-12-09Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER3729d270-64ac-4d2e-e063-6294a90aeb2c2025-12-09Exact identifier
application number: M020
Non Tinted Replenishing Daily ProtectionZINC OXIDELUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER372a41f6-40f6-4971-e063-6394a90a83e02025-12-09Exact identifier
application number: M020
Stay Shady Non-Tinted Mineral SunscreenZINC OXIDEAMOIE ALAYVILLA3b277237-3a2e-1fb0-e063-6294a90adf202025-12-09WarningsExact identifier
application number: M020
Stay Shady Non-Tinted Mineral SunscreenZINC OXIDEAMOIE ALAYVILLA3b27225f-4589-d915-e063-6294a90a72252025-12-09WarningsExact identifier
application number: M020
Replenishing Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC3738a0c3-5c07-e49b-e063-6394a90a38e92025-12-09Exact identifier
application number: M020
Replenishing Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC37385fc6-1cde-8aa6-e063-6294a90a60172025-12-09Exact identifier
application number: M020
Replenishing Tinted SunscreenZINC OXIDEBeauty Journey Studio LLC3738e5e0-f6d9-0568-e063-6294a90a67b62025-12-09Exact identifier
application number: M020
JAYSUING Matte Sun StickTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456b44da-02f3-93a0-e063-6294a90a8d062025-12-08WarningsExact identifier
application number: M020
JAYSUING Matte Sun StickTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456c2974-d499-7841-e063-6294a90a98eb2025-12-08WarningsExact identifier
application number: M020
JAYSUING Ginseng Moist Sun SerumTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456cfa70-f524-f5cb-e063-6394a90ae7dc2025-12-08WarningsExact identifier
application number: M020
Face and Body SunscreenNON-NANO ZINC OXIDE 25%Guangzhou Shengyanghui Industrial Trading Co., Ltd3ee96538-06e8-75b1-e063-6394a90a52852025-12-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85609-203-15856090203151.5 g in 1 BOTTLE, PUMP (85609-203-15) 1.5 g2020-02-12YesNoCurrent
85609-203-508560902035053 g in 1 BOTTLE, PUMP (85609-203-50) 53 g2019-03-08NoNoCurrent