FDA.reportPublic FDA data

Anew Platinum DayCream Broad Spectrum SPF 25

Product NDC
68577-252
11-digit product format
685770252
Labeler code
68577
Product ID
68577-252_56200250-0b5e-8b70-e063-6294a90a0a98
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, octinoxate, octisalate, oxybenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
COSMAX USA, CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-03
Substance
OXYBENZONE; OCTINOXATE; OCTISALATE; AVOBENZONE
Active strength
4; 7.5; 4.75; 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 Platinum DayCream Broad Spectrum SPF 25
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBENZONE4 g/100mL
OCTINOXATE7.5 g/100mL
OCTISALATE4.75 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
95OOS7VE0YInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal 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
56200212-bedc-6e1e-e063-6394a90a3666Available 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 272 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF30 CALENDULA SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY64580be7-868c-40fb-b7b8-840b417b25d32024-11-06WarningsExact identifier
application number: M020
KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY20ebe264-2f79-4eef-b83d-3f09a3ca28982024-11-06WarningsExact identifier
application number: M020
Cream Oil SunscreenZINC OXIDE, TITANIUM DIOXIDE SUNSCREENOwen Biosciences, Inc.b2ccdfea-1c27-42af-b9d8-752e9f91ae872024-11-05WarningsExact identifier
application number: M020
Vivant Day Treatment SPF 15OCTINOXATE 7.50% OCTISALATE 5.00%Vivant Pharmaceuticals, LLC10a95d0a-366f-0611-e063-6294a90abb442024-11-05WarningsExact identifier
application number: M020
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.1560a6b6-8d4a-6942-e063-6294a90a4a442024-11-04WarningsExact identifier
application number: M020
Bali Body Watermelon Tanning Oil SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd07d96576-fd78-acf3-e063-6394a90af45b2024-11-03WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Dry-Touch Face and Body Sunscreen Broad Spectrum UVA-UVB SPF 50ZINC OXIDEKenvue Brands LLC8f34c1f6-51fe-4719-ba1f-1e23c05e937b2024-11-01WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30ZINC OXIDEEdgewell Personal Care Brands LLCc8d6c731-2dfc-71c0-e053-2a95a90aa5b82024-11-01WarningsExact identifier
application number: M020
Hawaiian Tropic Sport Sunscreen Everyday ActiveAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc64918f-df4c-3a5e-e053-2995a90aea4b2024-11-01WarningsExact identifier
application number: M020
Byoma Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEBYOMA LIMITED25de7939-3b18-7f9e-e063-6394a90a23a92024-11-01WarningsExact identifier
application number: M020
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.cda67d41-d063-4936-a6b9-23376304eb422024-11-01WarningsExact identifier
application number: M020
Dr Edward Krulig New Melan Sunblock SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEKRULIG INTERNATIONAL, INC21c301d2-b283-40e1-bf26-b4bdde2782472024-10-31WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC77cdd346-d273-ed66-e053-2991aa0ae31d2024-10-31WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC767accea-c5b2-32dc-e053-2991aa0a33382024-10-31WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Broad-Spectrum Sunscreen SPF 50ZINC OXIDEZO Skin Health, Inc.f218c158-19aa-ab90-e053-2a95a90aaef32024-10-31WarningsExact identifier
application number: M020
Banana BoatZINC OXIDEEdgewell Personal Care Brands LLC1ce728be-966e-b662-e063-6394a90a0ba82024-10-30WarningsExact identifier
application number: M020
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENECOSMAX USA, INC.2596a17e-4042-3544-e063-6294a90aa4c92024-10-29WarningsExact identifier
application number: M020
SunbloczZINC OXIDEOlen Skin Care Corporation36fec1f1-5e8b-5764-e054-00144ff8d46c2024-10-29WarningsExact identifier
application number: M020
Sunblocz Baby and KidsZINC OXIDEOlen Skin Care Corporation35cbb9d5-639c-207a-e054-00144ff88e882024-10-29WarningsExact identifier
application number: M020
ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.fd7d40fe-178a-e1b1-e053-6294a90a29a12024-10-29WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68577-252-00685770252001 JAR in 1 CARTON (68577-252-00) / 50 mL in 1 JAR1 jar2024-01-03NoNoCurrent