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 294 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silk Line Silk Day Cream SPF 15OCTINOXATE, OCTOCRYLENE, OCTISALATEBiocosmetica Exel Argentina SRLb2965aba-fcde-16f6-e053-2995a90aa9d82024-06-30WarningsExact identifier
application number: M020
Sun Shield On-the-Glow Sheer Stick SPF40AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c237d5a-1663-e9a1-e063-6294a90a6a242024-06-30WarningsExact identifier
application number: M020
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEExelencia importers0d6d4098-4121-477e-b404-3ab18628ed682024-06-30WarningsExact identifier
application number: M020
Silk Line Silk Day Cream SPF 15OCTINOXATE, OCTOCRYLENE, OCTISALATEExelencia Importers, Corp.b2d35086-748b-55d0-e053-2995a90a18982024-06-30WarningsExact identifier
application number: M020
Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc28c51c59-dbfb-45e5-b536-6e5d5c5560d62024-06-28WarningsExact identifier
application number: M020
Sun Shield Body Glow SPF50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEKoco Life LLC180aa4d5-6dac-e658-e063-6394a90a32872024-06-28WarningsExact identifier
application number: M020
Rose Gold Sun Shield Body Glow SPF45AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1bf7d147-7051-2e76-e063-6294a90a1d132024-06-28WarningsExact identifier
application number: M020
Golden Amber Sun Shield Body Glow SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC1bf97569-024a-9ef1-e063-6394a90a28222024-06-28WarningsExact identifier
application number: M020
Jergens Natural Glow Face Daily Moisturizer for Fair/Medium SkinAVOBENZONE, OCTISALATE, OCTOCRYLENEKao USA Inc.365a98e0-737b-12b3-e054-00144ff8d46c2024-06-28WarningsExact identifier
application number: M020
Antioxidant Face Shield Mineral SPF30ZINC OXIDEKoco Life LLC1c31a971-0402-e12a-e063-6294a90ac91d2024-06-28WarningsExact identifier
application number: M020
Sun Essentials SPF Duo KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c329b86-664e-de1f-e063-6394a90a7c232024-06-28WarningsExact identifier
application number: M020
IT COSMETICS YOUR SKIN BUT BETTER CC PLUS NUDE GLOW Color Correcting Medium Coverage Skin Tint plus Brightening Glow Serum plus Broad Spectrum SPF 40 SunscreenHOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Ince879c055-9611-46a2-bcf6-8dd0a29a31292024-06-28WarningsExact identifier
application number: M020
Lancome Paris Absolue Makeup Broad Spectrum SPF 20 Sunscreen Absolute Replenishing Makeup for Dry and Very Dry SkinOCTINOXATEL'Oreal USA Products Inc90326e7e-8fdf-4221-afc0-208774d8ba6f2024-06-28WarningsExact identifier
application number: M020
LOreal Paris Collagen Moisture Filler Ultra Light Moisturizing Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc21fdc5e-236a-4a8e-ad59-1d9cd75074242024-06-28WarningsExact identifier
application number: M020
Kiehls Ultra Facial Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc6925c546-056e-4be8-b4e9-55da0b6b62b32024-06-28WarningsExact identifier
application number: M020
LOreal Paris Age Perfect Radiant Foundation Broad Spectrum SPF 50 Sunscreen with Antioxidants plus Concentrated SerumHOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc799c547c-a17a-43ee-92fc-061b5ec8a40c2024-06-28WarningsExact identifier
application number: M020
LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incf6457973-3718-44cd-a764-de0b089d4eee2024-06-28WarningsExact identifier
application number: M020
LOreal Paris Visible Lift Serum Absolute Advanced Makeup Broad Spectrum SPF 17 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc8598d56b-adcd-48e8-b6fc-77bc934009c72024-06-27WarningsExact identifier
application number: M020
MAYBELLINE NEW YORK INSTANT AGE REWIND ERASER TREATMENT MAKEUP OCTINOXATE BROAD SPECTRUM SPF 20 SUNSCREEN PLUS PROVITAMIN B5OCTINOXATEL'Oreal USA Products Inc12ec5a93-8c24-4ac9-94df-910dd8137e002024-06-27WarningsExact identifier
application number: M020
Kiehls Since 1851 Dermatologist Solutions AutoTone Discoloration and UV Solution Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc6dbbc8ce-9457-4405-bb38-aa0c7550c62c2024-06-27WarningsExact 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