FDA.reportPublic FDA data

Protec(tint) SPF 50

Manufacturer
PML NYC, LLC
Effective date
2026-04-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:53:45

Label at a glance#

ProductProtecTINT 20C
Active ingredientHOMOSALATE, ZINC OXIDE, OCTISALATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:Zinc Oxide 13.58%, Homosalate 7.0%, Octisalate 5.0%

OTC - PURPOSE 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

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.

WARNINGS SECTION

For External use only

Do not useon damaged or broken skin

When using this product,keep out of eyes. Rinse with water to remove

INDICATIONS & USAGE SECTION

Stop use and ask a doctorif rash occurs

DOSAGE & ADMINISTRATION SECTION

Directions

Apply generously and evenly 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

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 from 10 a.m.- 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients:IAqua/Water/Eau, Isononyl Isononanoate, Butyloctyl Salicylate, Propanediol, Silica, Glycerin,1,2-Hexanediol, Lecithin, Coco-Caprylate/Caprate, Cetearyl Alcohol, Lauryl Glucoside, Polyglyceryl-2 Dipolyhydroxystearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ectoin, Coco-Glucoside, Polyhydroxystearic acid, Citric Acid, Triethoxycaprylylsilane, Morinda Citrifolia Extract, Xanthan Gum, Sodium Phytate, Bentonite, Sodium Hyaluronate, Tocopherol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Protec(tint)

Daily SPF Tint

SPF 50

Broad Spectrum Tinted

Sunscreen SPF 50

1.18 fl. oz. / 35 ml.

CartonCarton

BottleBottleBottleBottle

SHADE LABELS

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-906-01ProtecTINT 20C35 mL in 1 TUBECREAM353
59735-906-02ProtecTINT 20C1 in 1 BOXCREAM13
59735-907-01ProtecTINT 26W35 mL in 1 TUBECREAM353
59735-907-02ProtecTINT 26W1 in 1 BOXCREAM13
59735-908-01ProtecTINT 32N35 mL in 1 TUBECREAM353
59735-908-02ProtecTINT 32N1 in 1 BOXCREAM13
59735-909-01ProtecTINT 34C35 mL in 1 TUBECREAM353
59735-909-02ProtecTINT 34C1 in 1 BOXCREAM13
59735-910-01ProtecTINT 58W35 mL in 1 TUBECREAM353
59735-910-02ProtecTINT 58W1 in 1 BOXCREAM13
59735-911-01ProtecTINT 10N35 mL in 1 TUBECREAM353
59735-911-02ProtecTINT 10N1 in 1 BOXCREAM13
59735-912-01ProtecTINT 24N35 mL in 1 TUBECREAM353
59735-912-02ProtecTINT 24N1 in 1 BOXCREAM13
59735-913-01ProtecTINT 22W35 mL in 1 TUBECREAM353
59735-913-02ProtecTINT 22W1 in 1 BOXCREAM13
59735-914-01ProtecTINT 30W35 mL in 1 TUBECREAM353
59735-914-02ProtecTINT 30W1 in 1 BOXCREAM13
59735-915-01ProtecTINT 46N35 mL in 1 TUBECREAM353
59735-915-02ProtecTINT 46N1 in 1 BOXCREAM13
59735-916-01ProtecTINT 42C35 mL in 1 TUBECREAM353
59735-916-02ProtecTINT 42C1 in 1 BOXCREAM13
59735-917-01ProtecTINT 52N35 mL in 1 TUBECREAM353
59735-917-02ProtecTINT 52N1 in 1 BOXCREAM13
59735-918-01ProtecTINT 14N35 mL in 1 TUBECREAM353
59735-918-02ProtecTINT 14N1 in 1 BOXCREAM13
59735-919-01ProtecTINT 40W35 mL in 1 TUBECREAM353
59735-919-02ProtecTINT 40W1 in 1 BOXCREAM13

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59735-91159735-911-01, 59735-911-02
59735-91859735-918-01, 59735-918-02
59735-90659735-906-01, 59735-906-02
59735-91359735-913-01, 59735-913-02
59735-91259735-912-01, 59735-912-02
59735-90759735-907-01, 59735-907-02
59735-91459735-914-01, 59735-914-02
59735-90859735-908-01, 59735-908-02
59735-90959735-909-01, 59735-909-02
59735-91959735-919-01, 59735-919-02
59735-91659735-916-01, 59735-916-02
59735-91559735-915-01, 59735-915-02
59735-91759735-917-01, 59735-917-02
59735-91059735-910-01, 59735-910-02

Ingredients#

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

DailyMed ingredient rows page 1 of 11 · 432 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
HYALURONATE SODIUMYSE9PPT4THIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PROPANEDIOL5965N8W85TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
COCO GLUCOSIDEICS790225BIACT
WATER059QF0KO0RIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
BENTONITEA3N5ZCN45CIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ECTOINE7GXZ3858RYIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HOMOSALATEV06SV4M95SACTIB
ZINC OXIDESOI2LOH54ZACTIB
OCTISALATE4X49Y0596WACTIB
TOCOPHEROLR0ZB2556P8IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
GLYCERINPDC6A3C0OXIACT
NONI FRUIT7829X3G2X5IACT
PHYTATE SODIUM88496G1ERLIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TOCOPHEROLR0ZB2556P8IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
GLYCERINPDC6A3C0OXIACT
NONI FRUIT7829X3G2X5IACT
PHYTATE SODIUM88496G1ERLIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-01-09monthly-update2026-06-03 17:52:01
12024-06-26full-release2026-06-01 00:14:21

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
ProtecTINT 20CHOMOSALATE, OCTISALATE, ZINC OXIDEPML NYC, LLC1bcc9f71-820f-eba2-e063-6394a90a33052026-04-14WarningsExact identifier
ndc (package): 59735-916-02
ndc (package): 59735-906-02
ndc (package): 59735-912-01
ndc (package): 59735-910-01
ndc (package): 59735-917-02
ndc (package): 59735-907-02
ndc (package): 59735-919-02
ndc (package): 59735-909-01
ndc (package): 59735-912-02
ndc (package): 59735-915-02
ndc (package): 59735-908-02
ndc (package): 59735-918-02
ndc (package): 59735-910-02
ndc (package): 59735-919-01
ndc (package): 59735-916-01
ndc (package): 59735-914-01
ndc (package): 59735-914-02
ndc (package): 59735-908-01
ndc (package): 59735-906-01
ndc (package): 59735-913-02
ndc (package): 59735-918-01
ndc (package): 59735-915-01
ndc (package): 59735-913-01
ndc (package): 59735-917-01
ndc (package): 59735-911-01
ndc (package): 59735-907-01
ndc (package): 59735-911-02
ndc (package): 59735-909-02
ndc (product): 59735-909
ndc (product): 59735-917
ndc (product): 59735-913
ndc (product): 59735-916
ndc (product): 59735-918
ndc (product): 59735-914
ndc (product): 59735-910
ndc (product): 59735-911
ndc (product): 59735-919
ndc (product): 59735-912
ndc (product): 59735-915
ndc (product): 59735-907
ndc (product): 59735-908
ndc (product): 59735-906
ndc11 (package): 59735091402
ndc11 (package): 59735091002
ndc11 (package): 59735091702
ndc11 (package): 59735091302
ndc11 (package): 59735091901
ndc11 (package): 59735090601
ndc11 (package): 59735091202
ndc11 (package): 59735090701
ndc11 (package): 59735091501
ndc11 (package): 59735091102
ndc11 (package): 59735090901
ndc11 (package): 59735091701
ndc11 (package): 59735091601
ndc11 (package): 59735091101
ndc11 (package): 59735091201
ndc11 (package): 59735090602
ndc11 (package): 59735091001
ndc11 (package): 59735091401
ndc11 (package): 59735091802
ndc11 (package): 59735090902
ndc11 (package): 59735091301
ndc11 (package): 59735091602
ndc11 (package): 59735091801
ndc11 (package): 59735090702
ndc11 (package): 59735090802
ndc11 (package): 59735090801
ndc11 (package): 59735091902
ndc11 (package): 59735091502
spl id: 4f77c110-9e98-6fdf-e063-6394a90a3c7c
spl set id: 1bcc9f71-820f-eba2-e063-6394a90a3305

Reported adverse events (FAERS/openFDA)#

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