FDA.reportPublic FDA data

Wellage Real Hyaluronic Watery Glow Sun Screen

Product NDC
81165-001
11-digit product format
811650001
Labeler code
81165
Product ID
81165-001_37aa2f7b-afa5-5cc9-e063-6294a90ae741
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
Hugel, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-22
Substance
HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength
3.5; 2.25; 1.425; 4.5 g/50mL; g/50mL; g/50mL; g/50mL
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
Wellage Real Hyaluronic Watery Glow Sun Screen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE3.5 g/50mL
OCTISALATE2.25 g/50mL
AVOBENZONE1.425 g/50mL
OCTOCRYLENE4.5 g/50mL

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
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
37aa2f7b-afa4-5cc9-e063-6294a90ae741Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81165-001-01Wellage Real Hyaluronic Watery Glow Sun Screen50 mL in 1 BOTTLE, PLASTICCREAM501
81165-001-02Wellage Real Hyaluronic Watery Glow Sun Screen1 in 1 BOXCREAM11
81165-001-03Wellage Real Hyaluronic Watery Glow Sun Screen2 in 1 BOXCREAM21

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 2 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Basil LemonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC277cb44d-608a-4ffc-a2a5-ac57d33d214c2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Black CherrySUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8f413bd6-258c-4c3c-89d1-369938c857202026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Cucumber LimeSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC5f15bee9-9bf4-4f27-a6b5-4205deb625f62026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Winter MelonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCe7792b4e-a6d2-487e-ba28-27b68e6d7e272026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm Vanilla BourbonAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC517040d1-e6ed-40ca-a46f-2f75403dbc3c2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Mango and MandarinSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8c55d1cd-cdd6-468b-8a17-b940c62101162026-09-08WarningsExact identifier
application number: M020
Jack Black Intensive Therapy Lip Balm Mango Chili LimeAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC51349d57-b14d-4798-8d68-03fbe3713d1e2026-09-08WarningsExact identifier
application number: M020
Jack Black Sun Guard Sunscreen SPF45SUNSCREENJack Black, LLC3cc86bb2-05ce-47eb-8c71-f4f116ca58402026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea ButterLIP BALM SUNSCREENJack Black, LLC518cb17a-fdaa-4a60-93fc-708305366eb82026-09-08WarningsExact identifier
application number: M020
Jack Black Lavender Lip Balm 0.25ozLIP BALM SUNSCREENJack Black, L.L.C.e8c6a6d9-1093-41f1-87d5-faf8583d43192026-09-08WarningsExact identifier
application number: M020
SPF15 lip balm 01OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8695305-b89d-c21c-e053-6394a90a0e842026-09-08WarningsExact identifier
application number: M020
Sunscreen stickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmuses Cosmetics (Ningbo) Co., Ltd.e9f963ee-a98c-efc1-e053-2a95a90aaf532026-09-08WarningsExact identifier
application number: M020
SPF30 Sunscreen 01AVOBENZONE ,HOMOSALATE,OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5b04751d-32e9-a7e2-e063-6294a90aefbd2026-09-08WarningsExact identifier
application number: M020
Juyasuyon Invisible SunscreenHOMOSALATE,OCTOCRYLENE,OCTISALATE,BEMOTRIZINOL,AVOBENZONEGuangdong Aimu Biological Technology Co., Ltd5ab335b5-bb9e-4642-e063-6294a90a39862026-09-05WarningsExact identifier
application number: M020
No7 Future Renew Defense Shield SPF 50AVOBENZONE, OCTINOXATE, OCTISALATEBCMC41cc2c52-c6a4-611c-e063-6294a90aae012026-09-03WarningsExact identifier
application number: M020
WALMART EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALMART, INC.58b5d0ce-9157-9dee-e063-6394a90ab5432026-09-02WarningsExact identifier
application number: M020
Chantecaille Ultra Sun Protection Sunscreen SPF 45AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEChantecaille Beaute Inc6186ea56-7d56-43f5-985d-a012f1296afa2026-09-02WarningsExact identifier
application number: M020
ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50AVOBENZONE, BEMOTRIZINOL, OCTISALATEGrace and Fire USA5739c5b9-00d8-75a8-e063-6394a90aa8c72026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC2d5fa597-08a8-41ca-ba9e-b52e41a5c70c2026-09-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81165-001-018116500010150 mL in 1 BOTTLE, PLASTIC50 mlHistorical
81165-001-02811650001021 in 1 BOXHistorical
81165-001-03811650001032 BOX in 1 BOX (81165-001-03) / 1 BOTTLE, PLASTIC in 1 BOX (81165-001-02) / 50 mL in 1 BOTTLE, PLASTIC (81165-001-01) 2 box2025-06-22NoNoCurrent