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 240 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sunbetter Broad Spectrum SPF 70 Sunscreen SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb879067b-9d7f-3a62-e053-2995a90a9d6b2025-01-06WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Kiss Lip Balm Coconut CrushAVOBENZONE, HOMOSALATE, OCTOCRYLENEBONDI SANDS (USA) INC.2b142875-d413-aebe-e063-6394a90aaca02025-01-06WarningsExact identifier
application number: M020
glo SKIN BEAUTY Oil Free SPF 40GLO SKIN BEAUTY OIL FREE SPF 40Hayden Caleel LLC6b27a508-8669-418f-bcb2-61a35b79a3a82025-01-05WarningsExact identifier
application number: M020
glo SKIN BEAUTY Luminous Liquid Foundation SPF 18GLO SKIN BEAUTY LUMINOUS LIQUID FOUNDATION SPF 18Hayden Caleel LLCdd863361-281d-45fe-a8c1-6e4c670809a52025-01-05WarningsExact identifier
application number: M020
glo Skin Beauty C-Shield Anti-Pollution Moisture Tint Broad Spectrum SPF 30GLO SKIN BEAUTY C-SHIELD ANTI-POLLUTION MOISTURE TINT BROAD SPECTRUM SPF 30Hayden Caleel LLC9dbe250b-1b88-43b7-8e24-c1f5aaba0f8d2025-01-05WarningsExact identifier
application number: M020
Wildberry Lip BalmLIP BALMCasad Company Inc.5e13dc33-67b7-4461-bec5-0c3edc72f8b42025-01-03WarningsExact identifier
application number: M020
Iced Pear Lip BalmLIP BALMCasad Company Inc.1d9a62dd-c11e-4f97-9164-edc84adbe05b2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SandalwoodZINC OXIDEEVER FAME PTE. LTD.2ace641a-b440-d0b3-e063-6394a90a86322025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SepiaZINC OXIDEEVER FAME PTE. LTD.2acf4b3b-e82d-d512-e063-6294a90a3fef2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 TruffleZINC OXIDEEVER FAME PTE. LTD.2acf4b3b-e830-d512-e063-6294a90a3fef2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 WalnutZINC OXIDEEVER FAME PTE. LTD.2acf75d2-8ad7-1bd3-e063-6294a90ac0be2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 WheatZINC OXIDEEVER FAME PTE. LTD.2acf92a1-6d2a-5517-e063-6294a90a74882025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Warm VanillaZINC OXIDEEVER FAME PTE. LTD.2acf9020-c779-31c2-e063-6294a90a1ab52025-01-03WarningsExact identifier
application number: M020
Earths Daughter Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad009bc-29ce-0ba6-e063-6294a90a75802025-01-03WarningsExact identifier
application number: M020
Earths Daughter Bing Cherry SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad07286-f8af-7a9f-e063-6394a90a6a242025-01-03WarningsExact identifier
application number: M020
Earths Daughter Vanilla Bean SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad0db95-a283-3c91-e063-6294a90ae5232025-01-03WarningsExact identifier
application number: M020
Earths Daughter Strawberry Breeze SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad129b7-4ecd-a967-e063-6294a90ad8c42025-01-03WarningsExact identifier
application number: M020
Earths Daughter Citrus Blast SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad18f4b-4251-be82-e063-6394a90acac52025-01-03WarningsExact identifier
application number: M020
Earths Daughter Creamy Coconut SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad1bb50-869e-8122-e063-6294a90ac7242025-01-03WarningsExact identifier
application number: M020
Glow Baby Brightening Setting Mist SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPacifica Beauty, LLCf2f53cf9-3717-07ff-e053-2a95a90a03fb2025-01-03WarningsExact 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