FDA.reportPublic FDA data

Facial Skin Shield Broad Spectrum SPF50 Plus

Product NDC
60289-302
11-digit product format
602890302
Labeler code
60289
Product ID
60289-302_a68b535e-91c6-44ba-86c1-917cb31b4847
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, ensulizole, homosalate, octisalate, and octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
AHAVA - Dead Sea Laboratories Ltd
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
AVOBENZONE; ENSULIZOLE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
.0284; .03; .073; .05; .0989 g/mL; g/mL; g/mL; g/mL; g/mL
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 Skin Shield Broad Spectrum SPF50 Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE.0284 g/mL
ENSULIZOLE.03 g/mL
HOMOSALATE.073 g/mL
OCTISALATE.05 g/mL
OCTOCRYLENE.0989 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
9YQ9DI1W42Internal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb62c700-be07-4fe3-b007-425a5f760b30Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60289-302-24Facial Skin Shield Broad Spectrum SPF50 Plus1 in 1 CARTONCREAM11
60289-302-24Facial Skin Shield Broad Spectrum SPF50 Plus50 mL in 1 BOTTLE, GLASSCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60289-302FACIAL SKIN SHIELD BROAD SPECTRUM SPF50 PLUS (AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) CREAM [AHAVA - DEAD SEA LABORATORIES LTD]1Current NDC, 2 package rows20250101_bb62c700-be07-4fe3-b007-425a5f760b30.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 126 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBASS & KLASS, INC36af24e2-015a-a9a7-e063-6294a90a2fce2025-12-15Exact identifier
application number: M020
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEBASS & KLASS, INC36add3a3-f1ff-3986-e063-6394a90ab7fe2025-12-15Exact identifier
application number: M020
Antioxidant Mineral Sunscreen Plus Primer Lightly TintedZINC OXIDETrue Beauty Brows & Skin Care37dc70ba-a6bb-fe09-e063-6394a90a51292025-12-15Exact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCbcbab676-fbe2-f0cc-e053-2a95a90ad4d22025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf14cf2b8-b110-1210-e053-2995a90a01022025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf1504311-4865-5499-e053-2995a90acdcd2025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf14d70f1-440b-900d-e053-2995a90a30a02025-12-15WarningsExact identifier
application number: M020
REVERSE Brightening Defense FluidAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATERodan & Fieldsdc230e1e-bfb8-4d7c-bad5-bff77d78220e2025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC MINERAL SPORT SPF50TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCbbf15e58-c160-d599-e053-2a95a90a06962025-12-14WarningsExact identifier
application number: M020
Mineral Sunscreen Stick SPF 50 Fragrance-FreeZINC OXIDECOOLA LLCee8706b0-ad42-403a-be7c-b660f040a2442025-12-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60289-302-24602890302241 BOTTLE, GLASS in 1 CARTON (60289-302-24) / 50 mL in 1 BOTTLE, GLASS2025-01-01NoNoCurrent