FDA.reportPublic FDA data

PRIME Prometics LipOil SPF 35 Nude Glow

Product NDC
68577-285
11-digit product format
685770285
Labeler code
68577
Product ID
68577-285_564a6566-442d-b933-e063-6294a90a6f9b
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
OIL
Route
TOPICAL
Labeler
COSMAX USA, CORP
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
Substance
ZINC OXIDE
Active strength
13.5 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
PRIME Prometics LipOil SPF 35 Nude Glow
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE13.5 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
564a6566-442c-b933-e063-6294a90a6f9bAvailable 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 160 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alabaster Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc3c4b7789-cd73-418e-94cb-834a06cb94082025-11-19WarningsExact identifier
application number: M020
Alabaster Beige Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incc29cef40-065d-1f8d-e053-2995a90a43e72025-11-19WarningsExact identifier
application number: M020
Bare Perfecting Makeup Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc0a506f55-ea6c-44d3-bab2-0a5875c437572025-11-19WarningsExact identifier
application number: M020
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inccd4da670-ad26-445e-a243-1e88b54d33352025-11-19WarningsExact identifier
application number: M020
Delicate Beige Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc6a6b8780-a11a-4602-aab4-1925d64f786e2025-11-19WarningsExact identifier
application number: M020
Flawless Effect Liquid Foundation SPF 15 Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc05615352-186b-4610-a719-16fc36e09bb32025-11-19WarningsExact identifier
application number: M020
Foundation Primer Plus SPF 15 MERLE NORMANOCTINOXATE, OCTISALATEMerle Norman Cosmetics, Inc582ce0b2-addc-4b87-9334-c8f515b10a162025-11-19WarningsExact identifier
application number: M020
Ivory Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc748a9d28-8814-4394-ad7d-0d6ba868b0bc2025-11-19WarningsExact identifier
application number: M020
Lip Conditioner SPF 15 Merle NormanOCTINOXATE,OCTISALATEMerle Norman Cosmetics, Incb28459dc-c2df-4f8b-8b37-0090e223e6e92025-11-19WarningsExact identifier
application number: M020
Lasting Foundation SPF 12 Merle NormanTITANIUM DIOXIDEMerle Norman Cosmetics, Incd31cfc74-7dcf-4af1-ba53-63fcad4144642025-11-19WarningsExact identifier
application number: M020
Preventage Firming Defense Creme Normal/ Oily Broad Spectrum SPF 15AVOBENZONE, OCTOCRYLENEMerle Norman Cosmetics, Incd5c97cdc-7f98-1a4f-e053-2995a90a089b2025-11-19WarningsExact identifier
application number: M020
Preventage Firming Defense Creme Normal/Dry Broad Spectrum SPF 15AVOBENZONE, OCTOCRYLENEMerle Norman Cosmetics, Inc.d0dc5744-82d1-2f51-e053-2a95a90a39722025-11-19WarningsExact identifier
application number: M020
Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 MD 70 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.e12f5324-ed27-4a2e-bf49-f39f7fe351cb2025-11-19WarningsExact identifier
application number: M020
Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 M50 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.3a30b330-7f5f-4a8e-b8bc-1cfaad72f9852025-11-19WarningsExact identifier
application number: M020
Sheer Defense Tinted Moisturizer SPF 15 L10 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.c892e067-5a79-4903-a1f8-d5a9962c1d5c2025-11-19WarningsExact identifier
application number: M020
Sheer Defense Tinted Moisturizer SPF 15 ML 30 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.0ad4ec84-7c82-4ab3-9070-a0764af123062025-11-19WarningsExact identifier
application number: M020
Sheer Defense Tinted Moisturizer SPF15 L20 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.4a08acf3-41e9-4021-9f4b-99a1fd86b2ec2025-11-19WarningsExact identifier
application number: M020
Simply Beige Perfecting makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incdeaa0035-d030-4831-b2be-8b8bba5d8f552025-11-19WarningsExact identifier
application number: M020
Sheer Defense Tinted Moisturizer SPF 15 ML 40 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.02a4e8f6-f257-4d30-8782-64b4d1622d462025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Ivory Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc976c6155-6650-419f-9821-dd6725d093812025-11-19WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68577-285-00685770285001 TUBE in 1 CARTON (68577-285-00) / 10 mL in 1 TUBE1 tube2025-10-01NoNoCurrent