FDA.reportPublic FDA data

Sun Bum Mist 45 Refreshing Sunscreen 1.35 OZ

Product NDC
69039-784
Requested package NDC
69039-784-01
11-digit product format
690390784
Labeler code
69039
Product ID
69039-784_3d4c70a7-f984-1fe5-e063-6394a90aec7d
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Sun Bum, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength
150; 30; 70; 50 mg/mL; mg/mL; mg/mL; mg/mL
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
Sun Bum Mist 45 Refreshing Sunscreen 1.35 OZ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE150 mg/mL
AVOBENZONE30 mg/mL
OCTOCRYLENE70 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c1c8b83-f37d-a29d-e063-6294a90a20a8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-784-01Sun Bum Mist 45 Refreshing Sunscreen 1.35 OZ40 mL in 1 BOTTLE, SPRAYSPRAY402

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 259 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum Medicated Lip Balm OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Companyf84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df12024-12-17WarningsExact identifier
application number: M020
Mentholatum Natural Ice Sport SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company57c35631-42d3-4c6c-bcbb-e2de92b45b132024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMary Kay Inc.5f09503e-c455-4ac2-8d07-e8e66c2daa322024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to MediumHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.b5ca4bed-4f89-4020-a055-9d11f4cd50582024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.e5fffd20-1d22-485a-9311-4cb4f9264f6f2024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.404990e4-9499-4186-b39d-afc31834d3342024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.6028e210-a8a3-4d84-a462-16a414c310522024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very LightHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.af22b3a5-ac72-4c2a-aa7e-6b5ca07d89e82024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30AVOBENZONE/OCTISALATE/OCTOCRYLENEMary Kay Inc.00f0f30d-236a-fd45-e063-6294a90a747d2024-12-17WarningsExact identifier
application number: M020
Softlips Cherry Cordial, Maple Butter, Frosted BerryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybab8447b-58b8-4160-a91e-05f9fd09ed1d2024-12-17WarningsExact identifier
application number: M020
STUDIO FIX FLUID BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEMAKEUP ART COSMETICSfb59afc1-1dc9-f783-e053-6394a90a196b2024-12-17WarningsExact identifier
application number: M020
Mary Kay Mineral Facial Sunscreen Broad Spectrum SPF30ZINC OXIDEMary Kay Inc.0e9b15e4-e59c-f266-e063-6394a90ab81c2024-12-17WarningsExact identifier
application number: M020
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREENOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEMAKEUP ART COSMETICSe5fd3e40-de1d-4cdd-b725-4a517514ca352024-12-17WarningsExact identifier
application number: M020
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35OCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICS2d034810-7210-4ad4-be23-ec2100f8c2f12024-12-17WarningsExact identifier
application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NVacda1640-0d35-43dc-8734-d47b00cc85ed2024-12-17WarningsExact identifier
application number: M020
Mary Kay Foundation PrimerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMary Kay Inc.59d25b44-1adb-4790-8ce6-2d847a06b8b32024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm The Go SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMary Kay Inc.cf7fb8f0-483d-443b-b381-086a255f07832024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm Sampler SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMary Kay Inc.0a9ee359-19c1-4266-8a51-a68f655de1512024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMary Kay Inc.d459e2f7-dc78-4519-9733-01495fc447a22024-12-17WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Tinted Mineral Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.2982ce67-f136-b93b-e063-6394a90a81ac2024-12-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69039-784-016903907840140 mL in 1 BOTTLE, SPRAY (69039-784-01) 40 ml2025-01-01NoNoCurrent