FDA.reportPublic FDA data

Very Emollient Body Daily Shade SPF15

Product NDC
61995-0371
11-digit product format
619950371
Labeler code
61995
Product ID
61995-0371_1e9153a7-0b87-0518-e063-6394a90adfbd
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
The Hain Celestial Group
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-01
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength
7.5; 5; 3; 2 g/100g; g/100g; g/100g; g/100g
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
Very Emollient Body Daily Shade SPF15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE7.5 g/100g
OCTISALATE5 g/100g
OCTOCRYLENE3 g/100g
AVOBENZONE2 g/100g

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
8eeb25a8-337d-c71b-e053-2995a90a091aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-07-31Very Emollient Daily Shade SPF 15
2024-07-30Very Emollient Daily Shade SPF 15
2021-02-05Very Emollient Daily Shade SPF 15
2021-01-29Very Emollient Daily Shade SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-0371-1Very Emollient Body Daily Shade SPF15340 g in 1 BOTTLE, PUMPLOTION34011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-0371VERY EMOLLIENT BODY DAILY SHADE SPF15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [THE HAIN CELESTIAL GROUP]11Current NDC, Legacy NDC, 1 package rows20240802_8eeb25a8-337d-c71b-e053-2995a90a091a.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 66 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREENHOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDEOracle Cosmetic Co., Ltd.21424f78-f8d5-6a9b-e063-6294a90ab7dc2026-02-02WarningsExact identifier
application number: M020
HAMPTON SUN SPF50 SUNSHIELD BODY GLOWHOMOSALATE 10% OCTOCRYLENE 10% AVOBENZONE 3% OCTICALATE 5%S&C Hampton Sun LLC26190992-9463-47ae-86a5-0dbc05be87732026-02-02WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENERite Aid Corporationfe9146ec-b85d-43da-a391-377960f2c7722026-02-02Warnings, Adverse reactionsExact identifier
application number: M020
sheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid Corporation299a6690-9746-4410-a625-7636f0b4a7542026-02-02Warnings, Adverse reactionsExact identifier
application number: M020
Dr. C. Tuna Sun Stick SPF 50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENEFarmasi US LLC49dc6040-b400-7f5b-e063-6394a90ac7d72026-02-02WarningsExact identifier
application number: M020
Naturium Dew Glow Moisturizer Mineral SPF 50ZINC OXIDEe.l.f. Cosmetics, Inc535f798f-d21d-92b2-e063-6294a90a72c72026-02-02WarningsExact identifier
application number: M020
Sol de Janiero Rio Radiance SPF 50 BodyZINC OXIDECosmetic Solutions LLC2d54727d-5dcc-4792-85e8-1a2f21fe9e3d2026-02-02WarningsExact identifier
application number: M020
Sky and Sol Face and Body Sunscreen Spf 50ZINC OXIDEDelta Ecommerce LLC47d9dc66-328f-4cab-e063-6394a90a279d2026-02-01WarningsExact identifier
application number: M020
e.l.f. Suntouchable Invisi-Stick Glitz SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f cosmetics,Inc.4b801bb3-8930-7e04-e063-6294a90adaa12026-02-01WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR CLEARAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationcedd7a3e-3334-437f-a283-482bcd0064ee2026-01-30WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationbf16e8b5-b717-4255-a7da-9abe3d1ad8b42026-01-30WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid Corporation372a8fba-b190-40fe-a1fc-fecf7f7afc352026-01-30Warnings, Adverse reactionsExact identifier
application number: M020
ALOE UP MEDICATED LIP BALM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLC859b6d3f-b1ca-4966-8f0c-f9afa0d5864c2026-01-30WarningsExact identifier
application number: M020
ALOE UP SPORT NATURAL BALM SPF-15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC3de029ed-97f7-4cb3-a32e-d412bf3b58742026-01-30WarningsExact identifier
application number: M020
Reef safe unscented SPF 50 mineral sunscreen 01TITANIUM DIOXIDE, ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.49a77ad4-508c-9617-e063-6394a90a56232026-01-30WarningsExact identifier
application number: M020
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33TITANIUM DIOXIDE AND ZINC OXIDECosmetic Solutions LLCd65ae1c9-dff5-4612-b8be-fa59bba03b812026-01-30WarningsExact identifier
application number: M020
Touch in SOL No Poreblem Airbrushed PrimerOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEBONNE Co., Ltd4685ff24-0bb0-3502-e063-6394a90abfee2026-01-29WarningsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEAldi, Incc7650d20-7cb9-4861-8a30-cf4a9cd424e92026-01-29Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEAldi, Inc32c0613e-0f5a-47f5-b2f3-f32ae07cbc762026-01-29Warnings, Adverse reactionsExact identifier
application number: M020
Vacation Original Coconut SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.a9a0b558-b8e6-44ea-9b57-6938837a04fb2026-01-29WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61995-0371-161995037101340 g in 1 BOTTLE, PUMP (61995-0371-1) 340 g2019-07-010000-00-00NoNoCurrent