FDA.reportPublic FDA data

I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing Cream

Manufacturer
Thirty7 LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:09

Label at a glance#

ProductI KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing Cream
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

Helps prevent sunburn. higher SPF gives more sunburn protection 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 Children under 6 months of age: ask a doctor. 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 therisk, regularly use a sunscreen with broad spectrum SPF of 15  or higher and other sun protection ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00 % Octisalate 5.00% Octocrylene 10.00 %

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • 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

not intended for ingestion For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Other Information:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun. 

Questions?

OTC - QUESTIONS SECTION

1-888-985-2237

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Children under 6 months of age: ask a doctor.
  • 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 therisk, regularly use a sunscreen with broad spectrum SPF 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.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Capric/Caprylic Triglyceride, Chamomilla Recutita (Chamomile) Extract, Coco-Caprylate/Caprate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Macadamia Ternifolia Nut Oil, Mangifera Indica (Mango) Butter, Parfum (Fragrance),  Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate-20, Prunus Amygdalus Dulcis (Almond) Oil, Punica Granatum (Pomegranate) Extract, Retinyl Palmitate (Vitamin A), Rosa Canina (Rose) Hips Oil, Rosmarinus Officinalis (Rose) Hips Oil, Sesamum Indicum (Sesame) Oil, Squalane, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Vitis Vinifera (Grape) Seed Oil

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82188-222-00I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing Cream1 in 1 CARTONLOTION12
82188-222-00I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing Cream50 mL in 1 JARLOTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82188-222I KNOW VERY NECESSARY BROAD SPECTRUM SPF-40 MOISTURIZING CREAM (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LOTION [THIRTY7 LLC]2Current NDC, Legacy NDC, 2 package rows20231112_6ff00b6e-1cc7-4cc4-842b-4e379f75e454.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82188-22282188-222-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARGAN OIL4V59G5UW9XIACT
SHEA BUTTERK49155WL9YIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
TRICAPRILIN6P92858988IACT
CHAMOMILEFGL3685T2XIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
HYALURONIC ACIDS270N0TRQYIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
LAVENDER OILZBP1YXW0H8IACT
MANGOI629I3NR86IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
ALMOND3Z252A2K9GIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SESAME OIL UNSAPONIFIABLESK9GA601CEGIACT
SQUALANEGW89575KF9IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
GRAPE SEED OIL930MLC8XGGIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing CreamAVOBENZONE, OCTISALATE, OCTOCRYLENEThirty7 LLC6ff00b6e-1cc7-4cc4-842b-4e379f75e4542023-11-11WarningsExact identifier
ndc (package): 82188-222-00
ndc (product): 82188-222
ndc11 (package): 82188022200
spl id: 09e2e5e3-ab0d-d4b0-e063-6294a90a1f57
spl set id: 6ff00b6e-1cc7-4cc4-842b-4e379f75e454

Reported adverse events (FAERS/openFDA)#

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