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
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
Sonage Roux Tinted Day Creme with SPF 30
Brand name suffix
Sheer Tinted Moisturizer
Listing expiration
2027-12-31

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 218 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Drs. pharmacy sunscreen SPF 50SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)0def5c19-b088-2ffb-e063-6394a90aa1092025-03-25WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 70SUNSCREEN SPF 70OL PHARMA TECH LLC. (Drs. Pharmacy)0def6fa1-b028-fad5-e063-6394a90a19132025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84521ZINC OXIDEe.l.f. Cosmetics, Inc.31329426-d952-ee5d-e063-6294a90a55f42025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84520ZINC OXIDEe.l.f. Cosmetics, Inc.31328845-9a67-d237-e063-6294a90a2a7f2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84519ZINC OXIDEe.l.f. Cosmetics, Inc.31327ea3-affd-ca13-e063-6294a90a72382025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84517ZINC OXIDEe.l.f. Cosmetics, Inc.3132641a-e593-a9e8-e063-6294a90acc802025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84518ZINC OXIDEe.l.f. Cosmetics, Inc.3132669c-e104-ae1e-e063-6294a90aee7f2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84514ZINC OXIDEe.l.f. Cosmetics, Inc.31324410-3142-89e1-e063-6294a90a22ee2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84515ZINC OXIDEe.l.f. Cosmetics, Inc.31324ff6-a091-a51b-e063-6294a90a1dbb2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84513ZINC OXIDEe.l.f. Cosmetics, Inc.3131d155-4c23-db51-e063-6294a90a00192025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50-84505ZINC OXIDEe.l.f. Cosmetics, Inc.312d171d-b057-96d1-e063-6394a90ac4292025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84511ZINC OXIDEe.l.f. Cosmetics, Inc.313175f3-e42a-b2a7-e063-6294a90abcb72025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84510ZINC OXIDEe.l.f. Cosmetics, Inc.3131696a-a37a-908b-e063-6294a90a5e952025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84512ZINC OXIDEe.l.f. Cosmetics, Inc.31318380-79fe-c0e0-e063-6294a90af4fc2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84508ZINC OXIDEe.l.f. Cosmetics, Inc.3131512e-f97b-718e-e063-6294a90aa3c12025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84509ZINC OXIDEe.l.f. Cosmetics, Inc.313147bc-0095-7cbd-e063-6294a90a7d282025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84507ZINC OXIDEe.l.f. Cosmetics, Inc.31314118-0fd6-5549-e063-6394a90a9d1f2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84506ZINC OXIDEe.l.f. Cosmetics, Inc.313119be-c1f2-4cb0-e063-6294a90a03ca2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84516ZINC OXIDEe.l.f. Cosmetics, Inc.312dd439-5cc8-e034-e063-6394a90a5c762025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84504ZINC OXIDEe.l.f. Cosmetics, Inc.223efabb-d018-c337-e063-6394a90a56052025-03-25WarningsExact 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