FDA.reportPublic FDA data

Broad Spectrum SPF 30 Tropical Sunscreen

Product NDC
65692-0577
11-digit product format
656920577
Labeler code
65692
Product ID
65692-0577_18e7fc6b-b40b-f790-e063-6294a90ad0f4
Type
HUMAN OTC DRUG
Nonproprietary name
Broad Spectrum SPF 30 Tropical Sunscreen
Dosage form
LOTION
Route
TOPICAL
Labeler
Raining Rose, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-20
Substance
OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE
Active strength
1.5; .9; 2.4; 3 g/30mL; g/30mL; g/30mL; g/30mL
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
Broad Spectrum SPF 30 Tropical Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE1.5 g/30mL
AVOBENZONE.9 g/30mL
OCTOCRYLENE2.4 g/30mL
HOMOSALATE3 g/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal 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
18e7fc6b-b40a-f790-e063-6294a90ad0f4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-0577-1Broad Spectrum SPF 30 Tropical Sunscreen30 mL in 1 BOTTLE, PLASTICLOTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0577BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN LOTION [RAINING ROSE, INC]1Current NDC, 1 package rows20240522_18e7fc6b-b40a-f790-e063-6294a90ad0f4.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 40 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf45f7953-c103-4900-e053-2a95a90ae3992026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c888ce-3a3f-972b-e053-2a95a90a4fe32026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKNI TINTPML NYC, LLCf4c44eb6-0a3d-2848-e053-2a95a90a58f32026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8925c-ac54-43b1-e053-2995a90a916c2026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8b011-5e1d-378c-e053-2a95a90a09cf2026-04-18WarningsExact identifier
application number: M020
EltaMD UV Daily SPF40ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.d967b7d0-453a-4420-886a-70ecf46528d22026-04-17WarningsExact identifier
application number: M020
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
application number: M020
HOLIKA HOLIKA ALOE CICA UV Defense SunscreenAVOBENZONE, HOMOSALATE, OCTISALATEEnprani Co., Ltd.4fa30449-5332-1492-e063-6394a90a585f2026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
application number: M020
FORGESKINMINERAL TALLOW SUNSCREENGUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD4fa7e67d-cfc5-9f73-e063-6394a90ada502026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.a251eb20-02e6-4b55-b969-c1bef2f9d7322026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair PinkTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.6684d69a-89ff-41e8-81f0-3e2367811a182026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.bf24d081-85f7-4a26-9416-ecff1fe59dec2026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.4a09a01a-404f-4b67-91e0-666153f550e82026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion N-LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.cf7c4445-0382-47ab-aba9-b40d63e4f1cc2026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.80c60ffa-69e0-4b31-bd0d-fc8ff9936ba02026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.0e18d601-700a-4c1c-a434-22582253bd952026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion BronzeTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.ddb3aa5e-cd1a-4792-b1b1-3604b368e0102026-04-17WarningsExact identifier
application number: M020
House of Colour Tinted Sunscreen SPF 50ZINC OXIDEHouse of Colour, Inc.763f5534-cda1-43f2-8a37-1eaa6a43c2e82026-04-17WarningsExact identifier
application number: M020
Sugargirl SPF 30 Sunscreen Illuminating Stick SunlightHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC28c9f019-34fe-4568-ba35-38eb3c4cb19e2026-04-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65692-0577-16569205770130 mL in 1 BOTTLE, PLASTIC (65692-0577-1) 30 ml2024-05-20NoNoCurrent