FDA.reportPublic FDA data

Hale and Hush Broad Spectrum SPF 30

Product NDC
83677-610
11-digit product format
836770610
Labeler code
83677
Product ID
83677-610_4839683f-5b57-ca9b-e063-6294a90a7f5f
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Eclectic Solutions LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-02
Substance
ZINC OXIDE
Active strength
13.5 g/100g
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
Hale and Hush Broad Spectrum SPF 30
Brand name suffix
SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE13.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0530904f-b02c-d8cf-e063-6294a90aa5a7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83677-610-58Hale and Hush Broad Spectrum SPF 30SPF 3055 g in 1 BOTTLE, DISPENSINGCREAM554

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83677-610HALE AND HUSH BROAD SPECTRUM SPF 30 SPF 30 (ZINC OXIDE) CREAM [ECLECTIC SOLUTIONS LLC]3Current NDC, 1 package rows20241201_0530904f-b02c-d8cf-e063-6294a90aa5a7.zip

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 22 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Play Everyday Sunscreen SPF 50 with Sunflower ExtractAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC0428eebc-4ffb-4981-b738-2c9ecf2a6a2e2026-06-04WarningsExact identifier
application number: M020
Unseen Sunscreen SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONESupergoop LLC21b3491f-7b02-9bc5-e063-6294a90a0dc32026-06-04WarningsExact identifier
application number: M020
Mineral Glowscreen Soft-Radiance Drops Golden HourZINC OXIDESupergoop LLC1f1be2a7-af96-d73d-e063-6394a90acc1a2026-06-04WarningsExact identifier
application number: M020
Play Antioxidant Body Mist WIth Vitamin C Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC975402e6-8c74-b18e-e053-2995a90a467e2026-06-04WarningsExact identifier
application number: M020
Derma E Sun Drops SPF 30ZINC OXIDEderma e76c29f24-e0d9-4235-b278-96e609bc58db2026-06-04WarningsExact identifier
application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
application number: M020
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
application number: M020
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
application number: M020
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
application number: M020
BLDG Active Skin Repair Sun Stick Performance SunscreenZINC OXIDEInnovacyn, Inc.a751fc1d-5ee4-4ecc-8ade-2568d91890c42026-06-02WarningsExact identifier
application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCAREHOMOSALATE OCTOCRYLENE ETHYLHEXYL SALICYLATEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5347c9a1-2239-b617-e063-6294a90ac6012026-06-02WarningsExact identifier
application number: M020
Sungboon Editor Hydro Booster Moisture SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEOlive International Co., Ltd.4ea2292a-571c-475c-a64c-cbdd1f51f2422026-06-02WarningsExact identifier
application number: M020
Sungboon Editor Daily Invisible Blurring SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOlive International Inc.42325963-0917-43c4-8fe0-130336c7fa812026-06-02WarningsExact identifier
application number: M020
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
application number: M020
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
application number: M020
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
application number: M020
4ocean REEF SAFE SUNSCREEN SPF 40ZINC OXIDEStream2Sea, LLC52d3d97c-a846-4721-acbe-52a525cb20112026-06-01WarningsExact identifier
application number: M020
APRILSKIN MUGWORT CALMING SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEAPR US INC50a7b64a-8b26-97ac-e063-6294a90ad77a2026-06-01WarningsExact identifier
application number: M020
Ultra Violette Future Screen Broad Spectrum SPF 50ZINC OXIDEGrace and Fire USA Inc.252fdc91-bbe2-58ec-e063-6294a90a50672026-06-01WarningsExact identifier
application number: M020
Ultra Violette Vibrant Screen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGrace and Fire USA Inc.2633a289-b3b2-b614-e063-6294a90ad2142026-06-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83677-610-588367706105855 g in 1 BOTTLE, DISPENSING (83677-610-58) 55 g2018-04-02NoNoCurrent