Sonage Roux Tinted Day Creme with SPF 30

Product NDC
69546-313
11-digit product format
695460313
Labeler code
69546
Product ID
69546-313_29b70a0d-e3eb-db95-e063-6394a90adfb2
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
ASA Universal Inc. dba: Sonage
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-08
Substance
ZINC OXIDE
Active strength
13 g/100mL
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
Sonage Roux Tinted Day Creme with SPF 30
Brand name suffix
Sheer Tinted Moisturizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE13 g/100mL

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
fd14d70c-6cd0-5de6-e053-6294a90a7addAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69546-313-02Sonage Roux Tinted Day Creme with SPF 30Sheer Tinted Moisturizer50 mL in 1 JARLOTION502
69546-313-02Sonage Roux Tinted Day Creme with SPF 30Sheer Tinted Moisturizer1 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69546-313SONAGE ROUX TINTED DAY CREME WITH SPF 30 SHEER TINTED MOISTURIZER (ZINC OXIDE) LOTION [ASA UNIVERSAL INC. DBA: SONAGE]2Current NDC, 2 package rows20241222_fd14d70c-6cd0-5de6-e053-6294a90a7add.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 169 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stream2Sea Broad Spectrum 20TITANIUM DIOXIDEStream2Sea, LLC1775d07d-6914-6928-e054-00144ff88e882025-11-06WarningsExact identifier
application number: M020
PHYSICAL TINTED MOISTURIZER SPF44ZINC OXIDE, TITANIUM DIOXIDEDrmtlgy, LLC483d0d28-56f3-4b37-af03-0331e1653d732025-11-06WarningsExact identifier
application number: M020
Neutrogena Rapid Wrinkle Repair Retinol Moisturizer Sunscreen Broad Spectrum SPF 30 DayAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCd3ebe2a9-434e-497c-8fed-b5c73c70a58b2025-11-05WarningsExact identifier
application number: M020
Clear Smart Shine Control Sunscreen Broad Spectrum SPF 25AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.a57bcf44-580d-520e-e053-2a95a90a69232025-11-05WarningsExact identifier
application number: M020
Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.865057ce-f617-4232-a60e-e23c120b0a732025-11-05WarningsExact identifier
application number: M020
Revitalize Solar Protection Fluid Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.29b3ee35-e849-4427-a455-37d92c4b995c2025-11-05WarningsExact identifier
application number: M020
Sarah Creal Brilliant Repair ShieldZINC OXIDESarah Creal LLC258ab6f2-f1a7-2d0d-e063-6294a90af34a2025-11-05WarningsExact identifier
application number: M020
Perricone MD Cold Plasma Plus Neck and Chest Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23a55301-2277-6e4f-e063-6394a90af1712025-11-05WarningsExact identifier
application number: M020
Sun Bum Face and Body Stick 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC20d9d60d-e0ce-a177-e063-6394a90a162e2025-11-05WarningsExact identifier
application number: M020
Obagi Nu-Derm Fx System Normal-Dry Skin Transformation Complexion Brightening SystemTITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLC4cbf1dc6-78b3-4e51-a53f-2018ac88136a2025-11-04WarningsExact identifier
application number: M020
SUNBEAT PROCARE FPS 50 KIDSHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, ENSULIZOLETecnoglobal, PH7 S.A. DE C.V.42c74ddf-70a3-f2b1-e063-6294a90a91a92025-11-04WarningsExact identifier
application number: M020
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEToshiki Pigment Co., ltd.b7163861-7084-5adf-e053-2995a90ae1992025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 8OCTINOXATE AND OXYBENZONETropical Seas, Inc.b5fa2883-998f-2128-e053-2995a90a5c842025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 15OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b557c9c5-6ea8-1d59-e053-2995a90aff682025-11-04WarningsExact identifier
application number: M020
Vertra Ehukai Beige Face Stick SPF 38TITANIUM DIOXIDEToshiki Pigment Co., ltd.b71619c4-a8ef-1dda-e053-2995a90aba502025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 45OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATETropical Seas, Inc.b4cafdf1-44e1-10c0-e053-2995a90ab3dc2025-11-04WarningsExact identifier
application number: M020
Reef Kids SPF 30 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.e226b07a-9f44-4b17-8f26-c86dcfa5dcda2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b4cc95f0-d684-5331-e053-2995a90a32952025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 20OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b55792e6-2ead-1fb1-e053-2995a90ac9152025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 8OCTINOXATE AND OXYBENZONETropical Seas, Inc.b5e68448-4131-1c6c-e053-2a95a90a014a2025-11-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69546-313-02695460313021 JAR in 1 CARTON (69546-313-02) / 50 mL in 1 JAR1 jar2023-06-08NoNoCurrent