FDA.reportPublic FDA data

GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREEN

Product NDC
84532-002
11-digit product format
845320002
Labeler code
84532
Product ID
84532-002_4d0ca758-2671-735e-e063-6394a90ac9d5
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
CLIO COSMETICS Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-09
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength
70; 45; 90; 28.5 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
GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE70 mg/mL
OCTISALATE45 mg/mL
OCTOCRYLENE90 mg/mL
AVOBENZONE28.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8d147089-709f-4468-a47d-9251e737c9a4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84532-002-01GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREEN50 mL in 1 TUBECREAM501
84532-002-02GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREEN1 in 1 CARTONCREAM11

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 301 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex Daily Care Moisturizing Lip Balm SPF 15 AssortedHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECarma Laboratories, Inc.22821e9d-eb3a-4e21-87ae-737b251255342024-04-03WarningsExact identifier
application number: M020
Meadow and Bark SPF 45 Mineral Shimmer SunscreenZINC OXIDEMeadow and Bark14bbd191-ef3b-628e-e063-6294a90a1e662024-04-03WarningsExact identifier
application number: M020
Meadow and Bark SPF 45 Mineral Sport SunscreenZINC OXIDEMeadow and Bark1494c0e1-97f5-411c-e063-6294a90ab2ca2024-04-03WarningsExact identifier
application number: M020
LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-FOCTINOXATE, ZINC OXIDEBEL STAR S Aea3a0e07-a277-48c8-e053-2a95a90a172f2024-04-02WarningsExact identifier
application number: M020
Rio Radiance SPF 50 BodySprayOCTOCRYLENE, OCTISALATE, AVOBENZONESol de Janeiro USA, Inc1520a151-70c4-8699-e063-6294a90adc6b2024-04-02WarningsExact identifier
application number: M020
Meijer SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer075efd92-1632-d8c8-e063-6294a90a8c1a2024-04-02WarningsExact identifier
application number: M020
Good Molecules Sheer Mineral Sunscreen SPF 30ZINC OXIDEGood Molecules, LLCe9596344-a7ab-f582-e053-2a95a90a55252024-04-02WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum MinisHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECarma Laboratories, Inc.f5c4186e-f167-40fc-b308-0b4406d3ec552024-04-02WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis HolidayAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECarma Laboratories, Inc.95d9a485-7418-437a-8e7d-ebcc090883562024-04-02WarningsExact identifier
application number: M020
Rejuvenating Priming Moisturizer BS Sunscreen SPF30ZINC OXIDEAllure Labs14cff1a3-89b9-f4da-e063-6394a90a1a412024-03-29WarningsExact identifier
application number: M020
Lemongrass Spa Products SPF 45 Tinted Mineral SunscreenZINC OXIDELemongrass Spa Products, LLC14bcbaf9-76a5-f8ba-e063-6294a90a91f62024-03-28WarningsExact identifier
application number: M020
Rubber Ducky SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECarefree Skincare Ventures, LLC14bd5cf9-423e-53a8-e063-6394a90a29f12024-03-28WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15FACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp132aab60-da19-7079-e063-6394a90a1d762024-03-27WarningsExact identifier
application number: M020
NAELI TINT Tinted Mineral Moisturizer SPF 50ZINC OXIDEALLI LLC25a88843-078b-4589-b8b7-ea439ba6a15b2024-03-27WarningsExact identifier
application number: M020
Rio Radiance SPF 50 BodyLotionZINC OXIDESOL DE JANEIRO USA, INC.14a85a88-c9a2-94ea-e063-6394a90a4e142024-03-27WarningsExact identifier
application number: M020
Rio Radiance SPF 50 Body OilOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONESOL DE JANEIRO USA, INC.14acf152-e72a-debb-e063-6294a90a243d2024-03-27WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0ac71c-e53a-5ff9-e063-6394a90a48072024-03-27WarningsExact identifier
application number: M020
EltaMD UV Pure SPF47ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.9afe900b-4186-4189-a871-ad6f26fc26e42024-03-27WarningsExact identifier
application number: M020
Eminence Daily Defense Tinted SPFZINC OXIDEEminence Organic Skin Care14854bad-317e-154d-e063-6294a90a884f2024-03-25WarningsExact identifier
application number: M020
SPF 50 Mineral Based Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD5cf0d2e3-d496-424c-ac75-70ff5b87e9ca2024-03-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84532-002-018453200020150 mL in 1 TUBE50 mlHistorical
84532-002-02845320002021 TUBE in 1 CARTON (84532-002-02) / 50 mL in 1 TUBE (84532-002-01) 1 tube2026-03-09NoNoCurrent