FDA.reportPublic FDA data

Avobenzone, Homosalate, and Octisalate

Manufacturer
PML NYC, LLC
Effective date
2026-04-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:53:51

Label at a glance#

ProductTula 24-7 Moisture Plus SPF 30 Hydrating Day with Sunscreen Broad Spectrum SPF 30
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE
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 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 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 sun, especially from 1...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3%

HOMOSALATE 7%

OCTISALATE 5%

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Sunscreen

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

OTC - DO NOT USE SECTION

Do not use

  • on damaged or broken skin

OTC - WHEN USING SECTION

When using this product

  • keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 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 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 sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, GLYCERIN, CETYL ALCOHOL, DIMETHICONE, HYDROGENATED VEGETABLE OIL, GLYCERYL STEARATE, PEG-100 STEARATE, LACTOCOCCUS FERMENT LYSATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, LACTOBACILLUS, LACTOBACILLUS FERMENT, HEDYCHIUM CORONARIUM ROOT EXTRACT, HYDROLYZED RICE PROTEIN, COLLAGEN AMINO ACIDS, SODIUM HYALURONATE, LACTIC ACID, CICHORIUM INTYBUS (CHICORY) ROOT EXTRACT, ALPHA-GLUCAN OLIGOSACCHARIDE, OLUS OIL/VEGETABLE OIL/HUILE VÉGÉTALE, CAMELINA SATIVA (CAMELINA) SEED OIL, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, TOCOPHERYL ACETATE, ASCORBYL PALMITATE, OLEA EUROPAEA (OLIVE) FRUIT OIL, PYRUS MALUS (APPLE) FRUIT EXTRACT, CITRULLUS LANATUS (WATERMELON) FRUIT EXTRACT, LENS ESCULENTA (LENTIL) FRUIT EXTRACT, INULIN, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, BETA VULGARIS (BEET) ROOT EXTRACT/BETA VULGARIS/EXTRAIT DE RACINE DE BETTERAVE, POLYMNIA SONCHIFOLIA (YACON) ROOT JUICE, SODIUM LACTATE, SODIUM PCA, CARBOMER, SODIUM HYDROXIDE, PENTYLENE GLYCOL, ETHYLHEXYLGLYCERIN, STEARYL ALCOHOL, CITRIC ACID, SODIUM BENZOATE, POTASSIUM SORBATE, PHENOXYETHANOL, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, SODIUM CHLORIDE, BUTYLENE GLYCOL, 1,2-HEXANEDIOL, MALTODEXTRIN, CALCIUM ALGINATE, CAPRYLYL GLYCOL, LECITHIN, PROPANEDIOL, TOCOPHEROL, XANTHAN GUM

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-844-545-1236

SPL UNCLASSIFIED SECTION

Distr. by : TULA LIFE, INC. NY, NY 10003

PRINCIPAL DISPLAY PANEL - 44 g CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TULA

SKINCARE

24-7 moisture + SPF 30

hydrating day cream

with sunscreen

BROAD SPECTRUM SPF 30


44 g (1.5 OZ)

TULATULA

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-105-01Tula 24-7 Moisture Plus SPF 30 Hydrating Day with SunscreenBroad Spectrum SPF 3044 g in 1 JARCREAM443
59735-105-02Tula 24-7 Moisture Plus SPF 30 Hydrating Day with SunscreenBroad Spectrum SPF 301 in 1 CARTONCREAM13

Products#

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

DailyMed product names page 1 of 2 · 55 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59735-10559735-105-01, 59735-105-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 53 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATERMELON231473QB6RIACT
.ALPHA.-GLUCAN OLIGOSACCHARIDES95658MI3WIACT
LACTIC ACID33X04XA5ATIACT
VICIA LENS FRUITZYZ076G9JHIACT
CALCIUM ALGINATE8P20S56HZIIACT
CAMELINA SATIVA SEED OIL12824X01L0IACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
MALTODEXTRIN7CVR7L4A2DIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM HYALURONATEYSE9PPT4THIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-100 STEARATEYD01N1999RIACT
CETYL ALCOHOL936JST6JCNIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CAPRYLYL GLYCOL00YIU5438UIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
XANTHAN GUMTTV12P4NEEIACT
PYRUS MALUS (APPLE) FRUITB423VGH5S9IACT
SODIUM CHLORIDE451W47IQ8XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CHICORY ROOT090CTY533NIACT
CITRIC ACID2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HYDROLYZED RICE PROTEIN (ENZYMATIC; 2000 MW)J9JP2XE45MIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CARBOMER0A5MM307FCIACT
INULINJOS53KRJ01IACT
BEETN487KM8COKIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL STEARATE230OU9XXE4IACT
HEDYCHIUM CORONARIUM ROOT92A6N0IQN9IACT
LACTOBACILLUS5307V7XW8IIACT
ASCORBYL PALMITATEQN83US2B0NIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT

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
Tula 24-7 Moisture Plus SPF 30 Hydrating Day with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, AND OCTISALATEPML NYC, LLC396dc7c7-a5e1-e1b2-e063-6294a90a75472026-04-15WarningsExact identifier
ndc (package): 59735-105-02
ndc (package): 59735-105-01
ndc (product): 59735-105
ndc11 (package): 59735010501
ndc11 (package): 59735010502
spl id: 4f86f975-6fb2-7970-e063-6394a90a0b44
spl set id: 396dc7c7-a5e1-e1b2-e063-6294a90a7547

Reported adverse events (FAERS/openFDA)#

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