FDA.reportPublic FDA data

PROJECT SUNSCREEN FESTIVAL MINERAL SUNSCREEN ROLL-ON LOTION SPF-40 (72688-105

Manufacturer
PROJECT SUNSCREEN | HealthSpecialty
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:15:58

Label at a glance#

ProductPROJECT SUNSCREEN FESTIVAL MINERAL SUNSCREEN ROLL-ON SPF-40
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
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

shake well before use apply liberally and evenly 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating:    immediately after towel drying    at least every 2 hours children under 6 months of age: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 5%

ZINC OXIDE 7%

PURPOSE

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

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 RASH OCCURS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF PRODUCTS IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating:
  •    immediately after towel drying
  •    at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • Sun Protection Measures. 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 10am–2pm
  •    Wear long-sleeved shirts, pants, hats, and sunglasses

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Dicaprylyl Ether, Propanediol, Glycerin, Isostearic Acid, Polyhydroxystearic Acid, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Cetyl PEG/PPG-10/1
Dimethicone, Stearyl/Octyldodecyl Citrate Crosspolymer, Sodium Chloride, Sodium Hyaluronate, Triethoxycaprylylsilane

QUESTIONS?

OTC - QUESTIONS SECTION

Call 424.262.9462, Monday – Friday, 9am – 5pm PST or visit projectsunscreen.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_PS_Festival_SPF-40_front01b LBL_PS_Festival_SPF-40_front

01b LBL_PS_Festival_SPF-40_back01b LBL_PS_Festival_SPF-40_back

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72688-105-112024-04-02C16284748780-11030e365-252a-111a-e063-dadaa90a10e2PROJECT SUNSCREEN FESTIVAL MINERAL SUNSCREEN ROLL-ON LOTION SPF-40 (72688-105
72688-105-112024-01-30C16284748780-11030e365-252a-111a-e063-dadaa90a10e2PROJECT SUNSCREEN FESTIVAL MINERAL SUNSCREEN ROLL-ON LOTION SPF-40 (72688-105

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72688-10572688-105-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DICAPRYLYL ETHER77JZM5516ZIACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
ISOSTEARIC ACIDX33R8U0062IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZOIC ACID8SKN0B0MIMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)V2W71V8T0XIACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYALURONATE SODIUMYSE9PPT4THIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
1522e539-a94f-fcbd-e063-6294a90af3f99bd98d26-d2e9-430f-9aff-2dc7f2b066002024-04-02WarningsExact identifier
spl set id: 9bd98d26-d2e9-430f-9aff-2dc7f2b06600

Reported adverse events (FAERS/openFDA)#

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