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 288 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bali Body Watermelon Tanning Oil SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd1fd37cec-807e-ddd3-e063-6294a90ae88e2024-08-16WarningsExact identifier
application number: M020
SunPlus SPF 30 Everyday Inspired Broad Spectrum SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLCfcae486a-5ea8-4f33-98bf-ec68a13d6b8a2024-08-15WarningsExact identifier
application number: M020
SunPlus SPF 50 Everyday Inspired Broad Spectrum SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLCa2a028a1-3f35-45f6-99a9-8a1c8b4c1f9b2024-08-15WarningsExact identifier
application number: M020
SKINRAYS Protective Bounce Butter Broad Spectrum SPF 30 Mineral Sunscreen by Glam upZINC OXIDESpigen Beauty Inc.94c0d586-8de5-45d1-8a82-07555996e61d2024-08-14WarningsExact identifier
application number: M020
FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDEESTEE LAUDER INC82db54ba-3ebd-4b70-b41c-b0d2faad7daa2024-08-13WarningsExact identifier
application number: M020
DERMA BRITE SPF 35OCTINOXATE, OCTISALATE, OXYBENZONEPHARMAGEL INTERNATIONAL INCfe10912e-00e3-406c-a80c-d9c991dc9f8b2024-08-13WarningsExact identifier
application number: M020
SUN THERAPE FACE AND BODY SPF-35AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEPHARMAGEL INTERNATIONAL INC6a96623f-c37c-4e67-925e-f133461d726d2024-08-13WarningsExact identifier
application number: M020
SUN THERAPE SPORT SPF-35HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTOCRYLENE, OCTISALATE, AVOBENZONEPHARMAGEL INTERNATIONAL INC0cc0de1e-c1c0-4a8a-ba5a-21e2470d61d92024-08-13WarningsExact identifier
application number: M020
BiocorneumAVOBENZONE, HOMOSALATE, MERADIMATE, OCTISALATE, AND OCTOCRYLENEBiodermis LLCef95f2b7-e438-4990-880d-81621edb20022024-08-13WarningsExact identifier
application number: M020
TiZO ULTRA ZINC Non-Tinted SPF 40 MINERAL SUNSCREEN FOR BODY and FACE With Antioxidants C and EZINC OXIDEFallien Cosmeceuticals, Ltd1f417082-5fd1-c95e-e063-6394a90a16ab2024-08-09WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1f4491ab-95b0-cc14-e063-6394a90a73ca2024-08-09WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb737146d-fb50-4ed6-ab5e-6aff3393992a2024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior54b07420-6a30-4481-99f5-a7d6a4df898c2024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65659277-cd30-453c-929e-3651c9f19da82024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior28ae9c39-eb79-4a19-8149-af8d8e7901ae2024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior05f7119a-0c92-4393-a62d-8e84ec451d202024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb90ee1ba-17b5-4367-9df3-e9e27217960c2024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorad5c5121-d75d-449d-a4db-a7b074787f682024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 00OCTISALATE, TITANIUM DIOXIDEParfums Christian Dior0018573d-922b-4642-9513-63481e9131d52024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior83b20b0d-c2db-4720-8434-57b73847ebca2024-08-06WarningsExact 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