FDA.reportPublic FDA data

ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN

Product NDC
68577-253
11-digit product format
685770253
Labeler code
68577
Product ID
68577-253_562053f4-75d6-a8b1-e063-6394a90a01a8
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTINOXATE,OXYBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
COSMAX USA, CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-03
Substance
OCTINOXATE; HOMOSALATE; OXYBENZONE; AVOBENZONE
Active strength
5; 8; 4; 2.85 g/100mL; g/100mL; g/100mL; 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
ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE5 g/100mL
HOMOSALATE8 g/100mL
OXYBENZONE4 g/100mL
AVOBENZONE2.85 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
V06SV4M95SInternal UNII lookup
95OOS7VE0YInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
562053d4-12bd-976e-e063-6394a90a59deAvailable on FDA.report

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 285 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB SPF 50 Pomegranate ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b48729-43d3-72b4-e053-2995a90a9d852024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 For Men Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b682aa-a194-09ff-e053-2a95a90ade732024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Birthday Cake Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b755af-2bd3-33cf-e053-2a95a90a99612024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Watermelon Serbert Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b77cc0-1ed5-c4ae-e053-2a95a90abc1a2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Hydrate 50 Sunscreen with Hyaluronic Acid and Collagen Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6e0db20-594b-30a8-e053-6394a90a71642024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Refine 50 Sunscreen with Niacinamide and Collagen Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6dfe973-bd88-e0e4-e053-6394a90ac9272024-10-15WarningsExact identifier
application number: M020
HEB Face Primer 30 Sunscreen Face Primer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH-E-Bf6e29c93-9fd9-36c6-e053-6394a90a17472024-10-15WarningsExact identifier
application number: M020
H.E.B. Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEH.E.B.c5279caf-3af9-d163-e053-2995a90a943b2024-10-15WarningsExact identifier
application number: M020
HEB Face 50 Clear Zinc SunscreenOCTOCRYLENE, ZINC OXIDEH.E.B.f6e3c883-0087-dcd6-e053-6394a90a12722024-10-15WarningsExact identifier
application number: M020
HEB Mineral Sunscreen SPF 50ZINC OXIDEH.E.B.de99343b-c74c-3f43-e053-2995a90ac9dd2024-10-15WarningsExact identifier
application number: M020
HEB SPF 55 Babies and Kids SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.f5660a97-57c8-61c7-e053-2995a90a01642024-10-15WarningsExact identifier
application number: M020
H.E.BSPF 50 SUNSCREENH.E.B362f726b-d52b-4dae-ade6-a47de47697ef2024-10-15WarningsExact identifier
application number: M020
HEB Sensitive 50 Mineral Sensitive Skin Sunscreen For FaceZINC OXIDEH.E.B.dfb43fc5-4968-f999-e053-2a95a90a08192024-10-15WarningsExact identifier
application number: M020
H.E.B BABYSPF 50 SUNSCREENH.E.B61273611-ab7a-4216-aebe-2c8d896602812024-10-15WarningsExact identifier
application number: M020
H.E.B BANANASPF 50 SUNSCREENH.E.Bb9a9837a-094b-4a57-a50c-5c1437deda7b2024-10-15WarningsExact identifier
application number: M020
HEB Solutions SunscreenSPORT SPF 100 LOTIONH.E.B9e3ea66c-d6a0-49ca-a3c0-8175e06174532024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenULTRA SPF 50 LOTIONH.E.B12c76c72-4411-48d5-b79b-c58703bf1fdd2024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenSPORT SPF 50 CONTINUOUS SPRAYH.E.B86ad5d30-f700-42a2-b810-dd2e3ed0f2d82024-10-15WarningsExact identifier
application number: M020
H.E.BSPF 50 SUNSCREENH.E.B1f8d4f91-9eb9-41de-9066-a7a08c7ff84f2024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenULTRA SPF 100 CONTINUOUS SPRAYH.E.Bbe80244d-da6d-4d37-b228-4d3fac335caf2024-10-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68577-253-00685770253001 JAR in 1 CARTON (68577-253-00) / 50 mL in 1 JAR1 jar2024-01-03NoNoCurrent