FDA.reportPublic FDA data

PRIME Prometics LipOil SPF 35 Nude Glow

Manufacturer
COSMAX USA, CORP
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:31:04

Label at a glance#

ProductPRIME Prometics LipOil SPF 35 Nude Glow
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Uses Helps prevent sunburn I used as directed with other sun protection measures ( see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

DIRECTIONS Apply generously and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use water resistant sunscreen if swimming or sweating Sun Protection Measures . Spending time in the sun increases your risk of certain cancer and early aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit in the sun...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Zinc Oxide 13.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

Uses

  • Helps prevent sunburn
  • I used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

WARNINGS

  • For external use only

OTC - DO NOT USE SECTION

  • Do not useon damaged or broken skin

OTC - WHEN USING SECTION

When using this productkeep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask doctorif rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of certain cancer and early aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months:

Ask doctor.

OTHER INFORMATION

OTHER SAFETY INFORMATION

OTHER INFORMATION

Protect Product in this container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:

Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Microcrystalline Wax, Silica Dimethyl Silylate, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Isononyl Isononanoate, Sorbitan Isostearate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Flavor, Menthone Glycerin Acetal, Iron Oxides (CI 77499), Dehydroacetic Acid, Rosa Canina Seed Oil, Mangifera Indica (Mango) Seed Butter, Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, and Tocopherol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-229-01PRIME Prometics LipOil SPF 35 Nude Glow10 mL in 1 TUBEOIL101
68577-229-01PRIME Prometics LipOil SPF 35 Nude Glow1 in 1 CARTONOIL11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-22968577-229-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIISOSTEARYL MALATEQBS8A3XZGQIACT
CI 774911K09F3G675IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
ISOSTEARIC ACIDX33R8U0062IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
SORBITAN OLIVATEMDL271E3GRIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
MANGIFERA INDICA (MANGO) SEED BUTTER4OXD9M35X2IACT
HYALURONIC ACIDS270N0TRQYIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
VP/HEXADECENE COPOLYMERKFR5QEN0N9IACT
CI 77499XM0M87F357IACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
ROSA CANINA SEED OILMHT97MG5P8IACT
HYDROGENATED POLYISOBUTENE (450 MW)7YR4ZFS62EIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
RICINUS COMMUNIS (CASTOR) SEED OILD5340Y2I9GIACT
DEHYDROACETIC ACID2KAG279R6RIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIB
CI 77492EX438O2MRTIACT
MENTHONE GLYCERIN ACETAL7QQ1EE6RCPIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
57c4f4c8-bf6a-9eef-e063-6394a90ae973478017cd-e225-6bd1-e063-6394a90a51bb2026-07-29WarningsExact identifier
spl set id: 478017cd-e225-6bd1-e063-6394a90a51bb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.