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 81 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Botao Baby Mineral Sunscreen LZINC OXIDEPeer Pharm Ltd.e1564df9-90cb-0b1f-e053-2a95a90acb5e2026-01-12WarningsExact identifier
application number: M020
FRE GLOW ME SPF 50 Lightweight Tinted Moisturizer Medium DeepZINC OXIDEPeer Pharm Ltd1d4559e7-91d4-6c85-e063-6394a90af8952026-01-12WarningsExact identifier
application number: M020
Sun and Shine - Mineral Sunscreen Clear Facial Stick SPF 50ZINC OXIDEPeer Pharm Ltd.20755fd4-ad05-4de2-84f5-fb29c0c5b1042026-01-12WarningsExact identifier
application number: M020
Botao - Grow Naturally Mineral Sunscreen Clear Facial Stick For Babies and Kids SPF 50ZINC OXIDEPeer Pharm Ltd.75763dc1-c762-42fc-a8fe-4d9d7bde0ce62026-01-12WarningsExact identifier
application number: M020
SUN and SHINE MINERAL SUNSCREENZINC OXIDEPeer Pharm Ltd.897eb75c-d7d6-4fce-afdd-f794fd8a82fd2026-01-12WarningsExact identifier
application number: M020
LINOZINC OXIDELino Cosmetics LLC262ef129-9453-2411-e063-6294a90ae2232026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50ZINC OXIDECrown Laboratoriesbb101039-dd3c-46da-e053-2a95a90aff8b2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50ZINC OXIDECrown Laboratoriesbfefb252-7e37-4675-e053-2995a90acb932026-01-12WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50ZINC OXIDECrown Laboratoriesbfefb36b-0858-6e4d-e053-2a95a90a01ce2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories9d20b230-2cce-4d90-e053-2995a90a4c032026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDECrown Laboratoriesc20fce25-8120-fe5d-e053-2a95a90a53a02026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer Face SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesbaed8202-21fd-3a43-e053-2a95a90ada322026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive Face SunscreenTITANIUM DIOXIDE, ZINC OXIDECrown Laboratories88dbd396-8955-271e-e053-2995a90a0a7a2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Baby SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories9d237fb7-4f5f-521d-e053-2a95a90a97342026-01-12WarningsExact identifier
application number: M020
PanOxyl Oil AM Control MoisturizerZINC OXIDECrown Laboratoriesf7e33151-e9a6-dae0-e053-6394a90a99952026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories1e4d49f4-9e77-48b5-bce5-ff04ed885a0f2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Baby SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories32d6e04a-fa30-ba48-e063-6394a90a1bbf2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories2f780daa-4c91-5a68-e063-6394a90afd412026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50ZINC OXIDECrown Laboratories99839894-9695-2cd1-e053-2995a90acba62026-01-12WarningsExact identifier
application number: M020
Blue Lizard SPF 15 Lip BalmZINC OXIDECrown Laboratories1bf8fb7e-9d5b-86d4-e063-6294a90afddc2026-01-12WarningsExact 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