FDA.reportPublic FDA data

DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35

Product NDC
49527-222
11-digit product format
495270222
Labeler code
49527
Product ID
49527-222_486e9b0e-bd13-8469-e063-6394a90a7ba2
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form
CREAM
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-31
Substance
HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength
70; 45; 30; 50 mg/mL; mg/mL; mg/mL; mg/mL
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
DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE70 mg/mL
OCTISALATE45 mg/mL
AVOBENZONE30 mg/mL
OCTOCRYLENE50 mg/mL

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
316bf6f8-7d30-2560-e063-6294a90afb8aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-222-01DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF351 in 1 CARTONCREAM13
49527-222-01DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF3575 mL in 1 BOTTLECREAM753
49527-222-02DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF3550 mL in 1 TUBECREAM503
49527-222-02DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF351 in 1 CARTONCREAM13
49527-222-03DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF3530 mL in 1 TUBECREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-222DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35 (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES LLC]2Current NDC, 5 package rows20250406_316bf6f8-7d30-2560-e063-6294a90afb8a.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 123 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Untinted Sheer DefenseTITANIUM DIOXIDE, ZINC OXIDEKristina Lerner35be50b7-a9af-29ee-e063-6394a90a45ba2025-12-15Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724ea3c-b018-c125-e063-6394a90a01f12025-12-15Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC37252429-d692-c05a-e063-6294a90a6af62025-12-15Exact identifier
application number: M020
Parasol Daily Mineral SunscreenZINC OXIDEBodi & Wax, LLC35d2fbeb-935b-f0a9-e063-6294a90acd792025-12-15Exact identifier
application number: M020
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation423c7e62-ad50-0dc3-e063-6294a90ad05a2025-12-15WarningsExact identifier
application number: M020
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC3699c107-d063-cc6f-e063-6394a90a6ad42025-12-15Exact identifier
application number: M020
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation44776529-3aa6-4fa3-b2ce-f624c4cf41bd2025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEJMSE Management, LLC36ec860f-2066-196c-e063-6294a90a21212025-12-15Exact identifier
application number: M020
Parasol Daily Mineral SunscreenZINC OXIDEBodi & Wax, LLC35d3262a-1d8d-2afa-e063-6294a90afd492025-12-15Exact identifier
application number: M020
Parasol Daily Mineral Sunscreen Non-TintedZINC OXIDEBodi & Wax, LLC35d37c2e-abc0-6bda-e063-6294a90a8fc32025-12-15Exact identifier
application number: M020
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC36999510-88f0-64fc-e063-6294a90a3d092025-12-15Exact identifier
application number: M020
Parasol Daily Mineral Sunscreen Non-TintedZINC OXIDEBodi & Wax, LLC35d3486c-c6e8-4d31-e063-6294a90a12192025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen CreamZINC OXIDEESTILO SALON & SPA LLC3699f6df-63b8-f255-e063-6394a90af2c42025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen CreamZINC OXIDEESTILO SALON & SPA LLC369a5997-7dbe-254d-e063-6394a90a5bef2025-12-15Exact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEESTILO SALON & SPA LLC369a8a99-c755-3c7f-e063-6394a90ac16c2025-12-15Exact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEESTILO SALON & SPA LLC369abc9d-9c20-5397-e063-6394a90a17232025-12-15Exact identifier
application number: M020
Sunshade Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37dec631-fdaf-fbdf-e063-6394a90a6c2b2025-12-15Exact identifier
application number: M020
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37527317-0f10-d7e6-e063-6394a90a35a62025-12-15Exact identifier
application number: M020
Sunshade Mineral Stick SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee31be-bfda-f052-e063-6294a90ac0bb2025-12-15Exact identifier
application number: M020
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC3751544d-e093-3d19-e063-6394a90aefc32025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49527-222-01495270222011 BOTTLE in 1 CARTON (49527-222-01) / 75 mL in 1 BOTTLE1 bottle2025-03-31NoNoCurrent
49527-222-02495270222021 TUBE in 1 CARTON (49527-222-02) / 50 mL in 1 TUBE1 tube2025-03-31NoNoCurrent
49527-222-034952702220330 mL in 1 TUBE (49527-222-03) 30 ml2026-01-15NoNoCurrent