I KNOW VERY NECESSARY BROAD SPECTRUM SPF-40 MOISTURIZING CREAM- avobenzone, octisalate, octocrylene lotion

I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing Cream by

Drug Labeling and Warnings

I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing Cream by is a Otc medication manufactured, distributed, or labeled by Thirty7 LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3.00 % Octisalate 5.00% Octocrylene 10.00 %

Purpose

Sunscreen

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

Warnings:

not intended for ingestion 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 or irritation develops and lasts.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use

Other Information:

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

Questions?

1-888-985-2237

Directions:

• 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:

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:

INGREDIENTS AND APPEARANCE

I KNOW VERY NECESSARY BROAD SPECTRUM SPF-40 MOISTURIZING CREAM 
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82188-222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARGAN OIL (UNII: 4V59G5UW9X)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TRICAPRILIN (UNII: 6P92858988)
CHAMOMILE (UNII: FGL3685T2X)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HYALURONIC ACID (UNII: S270N0TRQY)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALMOND (UNII: 3Z252A2K9G)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SESAME OIL UNSAPONIFIABLES (UNII: K9GA601CEG)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82188-222-00	1 in 1 CARTON	09/01/2021
1		50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2021

Labeler - Thirty7 LLC (107331862)