FDA.reportPublic FDA data

PROJECT SUNSCREEN KIDS MINERAL SUNSCREEN ROLL-ON LOTION SPF-50 (72688-104)

Manufacturer
PROJECT SUNSCREEN | HealthSpecialty
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:15:56

Label at a glance#

ProductKIDS MINERAL SUNSCREEN ROLL-ON SPF-50
Active ingredientZINC 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 15 MINUTES BEFORE SUN EXPOSURE REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING IMMEDIATELY AFTER TOWEL DRYING AT LEAST EVERY 2 HOURS 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 INCLUD...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 18%

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 15 MINUTES BEFORE SUN EXPOSURE
  • REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING
  • IMMEDIATELY AFTER TOWEL DRYING
  • AT LEAST EVERY 2 HOURS
  • 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
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Glycerin, Coconut Alkanes, Coco-Caprylate/Caprate, Bis-Stearyl Dimethicone, Cetearyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Isostearate, Galactoarabinan, Niacinamide, Capryloyl Glycerin/Sebacic Acid Copolymer, Polyhydroxystearic Acid, Tocopheryl Acetate, Physalis Angulata Extract, Caprylic/Capric Triglycerides, 1,2-Hexanediol, Propanediol, Caprylhydroxamic Acid

QUESTIONS?

OTC - QUESTIONS SECTION

CALL 424.262.9462 OR VISIT PROJECTSUNSCREEN.COM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PS-Kids-Bottle-Label-3oz-SPF_50-Here-Comes-SunPS-Kids-Bottle-Label-3oz-SPF_50-Here-Comes-Sun

Baby_SPF-50_Drug Facts BoxBaby_SPF-50_Drug Facts Box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72688-104-112024-04-02C16284748780-11030e365-0eaf-111a-e063-dadaa90a10e2PROJECT SUNSCREEN KIDS MINERAL SUNSCREEN ROLL-ON LOTION SPF-50 (72688-104)
72688-104-112024-01-30C16284748780-11030e365-0eaf-111a-e063-dadaa90a10e2PROJECT SUNSCREEN KIDS MINERAL SUNSCREEN ROLL-ON LOTION SPF-50 (72688-104)

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72688-10472688-104-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
GLYCERINPDC6A3C0OXIACT
COCONUT ALKANES1E5KJY107TIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
CETEARYL METHICONE (15000 MW)VY9RTR7MSYIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)V2W71V8T0XIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
GALACTOARABINANSL4SX1O487IACT
NIACINAMIDE25X51I8RD4IACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHYSALIS ANGULATAW4TKW9D5GGIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PROPANEDIOL5965N8W85TIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
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
1522e264-0139-cd76-e063-6294a90a85aa83a1dceb-e70e-4ed9-8bf2-0b07dd6249992024-04-02WarningsExact identifier
spl set id: 83a1dceb-e70e-4ed9-8bf2-0b07dd624999

Reported adverse events (FAERS/openFDA)#

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