I Know Very Necessary Broad Spectrum Spf-40 Moisturizing Cream

I Know Very Necessary Broad Spectrum Spf-40 Moisturizing Cream
SPL v2
SPL
SPL Set ID 6ff00b6e-1cc7-4cc4-842b-4e379f75e454
Route
TOPICAL
Published
Effective Date 2021-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octisalate (50 mg) Octocrylene (100 mg)
Inactive Ingredients
Aloe Vera Leaf Water Argan Oil Shea Butter Green Tea Leaf Tricaprilin Chamomile Cocoyl Caprylocaprate Ethylhexylglycerin Glycerin Helianthus Annuus Flowering Top Hyaluronic Acid Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Lavender Oil Mango Phenoxyethanol Polysorbate 20 Almond Punica Granatum Root Bark Vitamin A Palmitate Sesame Oil Unsaponifiables Squalane .alpha.-tocopherol Acetate Tridecyl Salicylate Grape Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-01

Description

Avobenzone 3.00 % Octisalate 5.00% Octocrylene 10.00 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00 % Octisalate 5.00% Octocrylene 10.00 %

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.
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.
Package Labeling:

Active Ingredients

Avobenzone 3.00 % Octisalate 5.00% Octocrylene 10.00 %



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

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.
If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

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


Structured Label Content

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
Purpose

Sunscreen

Warnings:

not intended for ingestion For external use only

Do Not Use (Do not use)
  • on damaged or broken skin.
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.
Package Labeling:

Active Ingredients

Avobenzone 3.00 % Octisalate 5.00% Octocrylene 10.00 %



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

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash or irritation develops and lasts.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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