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 246 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ulta Beauty Tinted Moisturizer Cream Spf 24 MediumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbc0ff10-fb2f-e637-e053-6294a90a0c292024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 DeepAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2984c64f-eaac-ecb6-e063-6394a90aeb122024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 TanAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2984a014-a56f-753b-e063-6294a90a13f52024-12-26WarningsExact identifier
application number: M020
Julep No Excuses Gel for Face SPF40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation298404c4-d4be-7395-e063-6294a90a86bf2024-12-26WarningsExact identifier
application number: M020
Cover FX Invisible Primer SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2983dd7c-7ca7-e952-e063-6394a90a30982024-12-26WarningsExact identifier
application number: M020
3LAB WW DAY SPF40 BROAD SPECTRUMHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE3LAB, INC2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e2024-12-26WarningsExact identifier
application number: M020
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation30b224f0-43f1-4c79-839e-3a970e4be3a52024-12-26WarningsExact identifier
application number: M020
CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREENHOMOSALATE, OCTISALATE, AND AVOBENZONECLINIQUE LABORATORIES LLCf4fe22b3-ccf2-4d67-8d20-5b5d3b69b4442024-12-25WarningsExact identifier
application number: M020
CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25TITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLCee7e2ded-b850-4e15-96a6-556111e521872024-12-25WarningsExact identifier
application number: M020
CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd1a3d76f-16dd-4533-8144-9a3175f6e15f2024-12-25WarningsExact identifier
application number: M020
DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15TITANIUM DIOXIDEESTEE LAUDER INCa04a9aaa-fa0f-4dde-a7a5-c4c561cc51b12024-12-25WarningsExact identifier
application number: M020
ESTEE LAUDER MULTI-DEFENSE AQUA UV gel BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEESTEE LAUDER INC0770e251-95d0-43de-88f1-bc0a29811e4e2024-12-25WarningsExact identifier
application number: M020
MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMAKEUP ART COSMETICSc26ef380-1309-4a41-862f-eb319d38673d2024-12-25WarningsExact identifier
application number: M020
STUDIO FIX FLUID SPF 15 BROAD SPECTRUMOCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICSff48435d-245a-4037-9afb-caee83c4c4152024-12-25WarningsExact identifier
application number: M020
ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.0fe63edf-7a49-4b33-88f1-f480f889d1942024-12-25WarningsExact identifier
application number: M020
DR. ANDREW WEIL FOR ORIGINS MEGA-BRIGHT SPF 30 SKIN TONE CORRECTING oil FREE MOISTURIZER BROAD SPECTRUM SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.8e8c495e-d439-4735-a7cc-b44081b75b272024-12-25WarningsExact identifier
application number: M020
VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15AVOBENZONE, OCTISALATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.0fac5204-df18-4774-bb53-115513cb7ff02024-12-25WarningsExact identifier
application number: M020
LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INC66e48ce0-9a5b-4250-b07b-1622b3814c3e2024-12-25WarningsExact identifier
application number: M020
ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC2f93580c-c8e9-4822-91bf-a749cf4deb4e2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b14a17-cab9-1b3e-e063-6394a90afe5d2024-12-25WarningsExact 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