FDA.reportPublic FDA data

DewyVita Zero Spot Sunscreen

Product NDC
87350-100
11-digit product format
873500100
Labeler code
87350
Product ID
87350-100_497ca8cd-50e6-6347-e063-6294a90a1e5f
Type
HUMAN OTC DRUG
Nonproprietary name
Octocrylene, Homosalate, Octisalate, Avobenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
BAREUNPLAN CO.,LTD.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-21
Substance
OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE
Active strength
1.176; 1.752; .696; 2.16 g/24g; g/24g; g/24g; g/24g
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
DewyVita Zero Spot Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE1.176 g/24g
HOMOSALATE1.752 g/24g
AVOBENZONE.696 g/24g
OCTOCRYLENE2.16 g/24g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal 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
497c98c3-d809-52e0-e063-6294a90acca2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
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
87350-100-01DewyVita Zero Spot Sunscreen50 g in 1 CASECREAM501
87350-100-02DewyVita Zero Spot Sunscreen1 in 1 CONTAINERCREAM11

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 14 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UV RESTORE FACE SERUM SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA564b8070-ee59-0c24-e063-6294a90ad9a92026-07-10WarningsExact identifier
application number: M020
COCO-EVE COCONUT MILK BODY SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA564b80c2-16e0-fb5f-e063-6394a90a50d22026-07-10WarningsExact identifier
application number: M020
COCO EVE SUNNY HONEY HIGHLIGHTER BODY SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECOSMAX USA564b9b1f-3d5b-4349-e063-6294a90a3b772026-07-10WarningsExact identifier
application number: M020
NORWEX Lip Glaze Broad Spectrum SPF 30 HazelnutZINC OXIDECOSMAX USA564ba912-c44b-4940-e063-6294a90a28fa2026-07-10WarningsExact identifier
application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA564bbb5f-4000-390d-e063-6294a90a408d2026-07-10WarningsExact identifier
application number: M020
PEACH AND LILY SUN COVER MINERAL SUNSCREEN SPF 30ZINC OXIDECOSMAX USA564bb5f9-5ac5-548b-e063-6394a90a84622026-07-10WarningsExact identifier
application number: M020
ILLUSION LUMINOUS GLOW FOUNDATIONAVOBENZONE, HOMOSALATE, AND OCTISALATEKingdom Animalia, LLC DBA Hourglass Cosmeticscf6a7e1a-7bca-439c-808a-80262f095f842026-07-10WarningsExact identifier
application number: M020
Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 30AVOBENZONE, HOMOSALATE, AND OCTISALATEThe Procter & Gamble Manufacturing Company30a063fa-e537-a2c1-e063-6394a90a6a832026-07-09WarningsExact identifier
application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 15 SensitiveOCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company3cb971e1-34f1-ee89-e063-6394a90a52a92026-07-09WarningsExact identifier
application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 30 SensitiveOCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Company3cb9de81-f05e-9697-e063-6394a90a69c52026-07-09WarningsExact identifier
application number: M020
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
application number: M020
Sunny C Sunscreen SPF 50SUNNY C SUNSCREENMIXIK, INC.4ed2a482-6c63-69f5-e063-6394a90ad3ee2026-07-08WarningsExact identifier
application number: M020
Ultra Violette Supreme Screen Broad Spectrum SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGrace and Fire USA Inc.24389324-19db-7eb5-e063-6394a90ad7fb2026-07-08WarningsExact identifier
application number: M020
ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE,OXYBENZONECOSMAX USA, CORPORATION562053d4-12bd-976e-e063-6394a90a59de2026-07-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
application number: M020
Sun Protection Mineral SPF 30ZINC OXIDEderma ebf6474a7-a21f-49cb-86e6-e5c40dbd34c32026-07-08WarningsExact identifier
application number: M020
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
application number: M020
Bath and Body Works SPF Pink DreamAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.560785f5-9126-12ba-e063-6294a90ac9462026-07-07WarningsExact identifier
application number: M020
Bath and Body Works SPF Sunkissed BerryAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.56078698-8655-12bd-e063-6294a90ad34c2026-07-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87350-100-018735001000150 g in 1 CASE50 gHistorical
87350-100-02873500100021 CASE in 1 CONTAINER (87350-100-02) / 50 g in 1 CASE (87350-100-01) 1 case2026-01-21NoNoCurrent