FDA.reportPublic FDA data

Solar Knight SPF 40 Broad Spectrum

Product NDC
85697-203
11-digit product format
856970203
Labeler code
85697
Product ID
85697-203_459c25fb-ce8c-c31a-e063-6294a90a3bb8
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
MASCARENAS ENTERPRISES, INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-24
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
38; 80 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Solar Knight SPF 40 Broad Spectrum
Listing expiration
2027-12-31

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
36c27c91-22ac-205c-e063-6294a90ab379Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85697-203-50Solar Knight SPF 40 Broad Spectrum53 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 280 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB SPF 50 Kids Purple Mineral Sunscreen Stick Grape ScentedZINC OXIDEH.E.B.f58ed2f9-67c3-ce91-e053-2995a90a12292024-10-15WarningsExact identifier
application number: M020
HEB Shimmer Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5930029-4c96-2576-e053-2995a90a7bed2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Birthday Cake SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5a3313e-4935-1ce3-e053-2a95a90a6ad12024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 White Gardenia Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b6caf2-ebff-79fb-e053-2995a90ac2f82024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 For Men SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf59461e3-9521-6a7b-e053-2a95a90a73b82024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Pink Peony SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf5a2c266-6fc9-21ae-e053-2995a90aec0e2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Pink Peony Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b7172a-b8fc-0d11-e053-2a95a90a9f732024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Peach Bellini Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5cbac04-361f-9226-e053-2995a90a2d7b2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Cucumber Water Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5d933cf-3461-8b03-e053-2a95a90ad79f2024-10-15WarningsExact identifier
application number: M020
HEB Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENEH.E.Bf6ce4ea0-d92f-368c-e053-6294a90a2a812024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 White Gardenia SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf5a2702c-5451-58a1-e053-2a95a90adb8e2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Strawberry Daquiri Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5cb5f9a-6691-37c3-e053-2a95a90a9af02024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Rosewater Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5db7ec6-0e9b-7044-e053-2a95a90a1e482024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Pomegranate ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b48729-43d3-72b4-e053-2995a90a9d852024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 For Men Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b682aa-a194-09ff-e053-2a95a90ade732024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Birthday Cake Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b755af-2bd3-33cf-e053-2a95a90a99612024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Watermelon Serbert Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b77cc0-1ed5-c4ae-e053-2a95a90abc1a2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Hydrate 50 Sunscreen with Hyaluronic Acid and Collagen Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6e0db20-594b-30a8-e053-6394a90a71642024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Refine 50 Sunscreen with Niacinamide and Collagen Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6dfe973-bd88-e0e4-e053-6394a90ac9272024-10-15WarningsExact identifier
application number: M020
HEB Face Primer 30 Sunscreen Face Primer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH-E-Bf6e29c93-9fd9-36c6-e053-6394a90a17472024-10-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85697-203-508569702035053 g in 1 BOTTLE, PUMP (85697-203-50) 53 g2019-06-24NoNoCurrent