FDA.reportPublic FDA data

COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden Hour

Manufacturer
COOLA, LLC
Effective date
2024-02-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:08:15

Label at a glance#

ProductCOOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden Hour
Active ingredientTITANIUM DIOXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn If 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

Apply liberally 15 minutes before sun exposure Reapply: • After 80 minutes of swimming or sweating. • Immediately after towel drying • At least every 2 hours Sun Protection Measure: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: • Limit tim...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide - 5.6%

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If 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

  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if skin 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 a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply: • After 80 minutes of swimming or sweating. • Immediately after towel drying • At least every 2 hours
  • Sun Protection Measure: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. to 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sun glasses.

INACTIVE INGREDIENT SECTION

Citrus Aurantium Dulcis (Orange) Fruit Water (ORGANIC), Water, Oryza Sativa (Rice) Bran Oil (ORGANIC), Dicaprylyl Carbonate, Propanediol, Cocoglycerides, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Euterpe Oleracea (Acai) Fruit Oil (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Helianthus Annuus (Sunflower) Seed Extract (ORGANIC), Cucumis Sativus (Cucumber) Fruit Extract (ORGANIC), Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Rosa Damascena Leaf Cell Extract, Rosa Gallica Flower Extract, Rosa Centifolia Leaf Cell Extract, Rosa Alba Leaf Cell Extract, Commiphora Myrrha Leaf Cell Extract, Plankton Extract, Glycerin (ORGANIC), Iron Oxides, Caprylyl Glycol, Octyldodecyl Oleate, Aluminum Hydroxide, Hydrolyzed Wheat Protein/PVP Crosspolymer, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Sodium Citrate, Hydrogen Dimethicone, Flavor

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Call 760-940-2125

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-047-01COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden Hour1 in 1 CARTONLOTION15
79753-047-01COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden Hour44 mL in 1 BOTTLE, GLASSLOTION445

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-047COOLA ROSILLIANCE MINERAL TINTED FACE MOISTURIZER SPF 30 GOLDEN HOUR (TITANIUM DIOXIDE) LOTION [COOLA, LLC]5Current NDC, Legacy NDC, 2 package rows20240203_edfda0f5-0f72-5cc7-e053-2a95a90ae38d.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-04779753-047-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
CUCUMBERYY7C30VXJTIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ROSEMARYIJ67X351P9IACT
XANTHAN GUMTTV12P4NEEIACT
ORANGE5EVU04N5QUIACT
ROSA X ALBA FLOWER OILFF1Y064QVOIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SAFFLOWER OIL65UEH262ISIACT
ROSA CENTIFOLIA WHOLEFQ84CRP97PIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
PROPANEDIOL5965N8W85TIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ROSA GALLICA FLOWERX8W61WUV70IACT
GLYCERINPDC6A3C0OXIACT
COMMIPHORA MYRRHA WHOLEUU81N77RI7IACT
SUNFLOWER SEEDR9N3379M4ZIACT
SODIUM CITRATE1Q73Q2JULRIACT
ACAI OILZ0W6766A2WIACT
SUNFLOWER OIL3W1JG795YIIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
COCO-GLYCERIDESISE9I7DNUGIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
RICE BRAN OILLZO6K1506AIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
WATER059QF0KO0RIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)J2S07SB0YLIACT
OCTYLDODECYL OLEATEMCA43PK7MHIACT

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
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden HourTITANIUM DIOXIDECOOLA, LLCedfda0f5-0f72-5cc7-e053-2a95a90ae38d2024-02-02WarningsExact identifier
ndc (package): 79753-047-01
ndc (product): 79753-047
ndc11 (package): 79753004701
spl id: 106b718b-2ad2-538c-e063-6394a90ace3c
spl set id: edfda0f5-0f72-5cc7-e053-2a95a90ae38d

Reported adverse events (FAERS/openFDA)#

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