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 103 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MINERAL DEFENSE SPORT ANTIOXIDANT FACE SUNSCREEN SPF-50ZINC OXIDESOLARA SUNCARE, INC.f5242c7d-09e1-4141-8de1-a89bd7981ca62025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - TIME TRAVELER SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.f7ad1b52-6d9d-4a12-a6ab-6584ffc39cc92025-12-22WarningsExact identifier
application number: M020
Go Daily Defense Soothing Mineral Face Sunscreen SPF-30ZINC OXIDESOLARA SUNCARE, INC.fd040893-b1e5-783f-e053-6294a90ac2162025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - CLEAN FREAK SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.0fc8fadf-69fc-40ad-b4ca-d96dd2b30f952025-12-22WarningsExact identifier
application number: M020
GUARDIAN ANGEL SUPER PEPTIDE SUNSCREEN MILK SPF-50ZINC OXIDESOLARA SUNCARE, INC.f3bb46e8-a9a5-b184-e053-2995a90afca72025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - POUT PROTECTOR SPF-15ZINC OXIDESOLARA SUNCARE, INC.ab6a326d-3b93-4122-a9f2-05e8203d31ef2025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - FORTUNE TELLER SPF-30ZINC OXIDESOLARA SUNCARE, INC.f434de33-5da8-57ef-e053-2a95a90a85022025-12-22WarningsExact identifier
application number: M020
SPF 50 Kids Sunscreen EquateAVOBENZONE, HOMOSALATE, OCTOCRYLENEWalmart Inc46919f43-2dee-57b1-e063-6294a90a15eb2025-12-22WarningsExact identifier
application number: M020
SPF 30 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalmart Inc46919f45-e3f3-4ed0-e063-6294a90a98352025-12-22WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen daybreak Shimmer Sunscreen for the faceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451bb734-d54d-e24e-e063-6394a90a1adb2025-12-21WarningsExact identifier
application number: M020
CabanaClear Illuminating SPF 50HOMOSALATE, OCTISALATE, AVOBENZONENAKED SUNDAYS PTY LTD47d1a39e-f645-c33d-e063-6394a90ad1ef2025-12-21WarningsExact identifier
application number: M020
THE MELT MIST Sheerest Mineral Mist Suncare for BodyTITANIUM DIOXIDE, ZINC OXIDEDune Suncare, Inc.465d3277-7798-512a-e063-6294a90a20652025-12-20WarningsExact identifier
application number: M020
THE SLIP Invisible Cooling Suncare for Face and BodyAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.465e1ba2-e967-edb9-e063-6294a90aa31c2025-12-20WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 9NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7287078e-67ff-41fe-bc8d-59b2146f5dc92025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb6095639-e2ee-418e-b4f1-e59da1bd92162025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8c6466a6-4f11-4210-bb02-eb31c15984cd2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior07f8282b-047b-4be1-8779-39ed5dd6fb5d2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5a8c67c1-aeba-490d-8347-a30916efcf3b2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior739450b0-8cd7-41de-8cd0-1827e02478c62025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior08b0e056-583a-474b-aaaa-ecea057030442025-12-19WarningsExact 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