No Bs Moisturizer Spf20

No Bs Moisturizer Spf20
SPL v4
SPL
SPL Set ID 142f3610-85da-408d-8fa5-3773167ffc9f
Route
TOPICAL
Published
Effective Date 2023-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (50 mg) Octisalate (30 mg) Avobenzone
Inactive Ingredients
Alkyl (c12-15) Benzoate Water Butylene Glycol Shea Butter Green Tea Leaf Medium-chain Triglycerides Carboxypolymethylene Cetostearyl Alcohol Cetearyl Glucoside Orange Oil Coconut Oil Diethylene Glycol Monoethyl Ether Ethylhexylglycerin Nori Glycerin Hyaluronic Acid Isopropyl Myristate Isostearyl Palmitate Mangifera Indica Seed Butter Palmitoyl Tripeptide-1 Palmitoyl Tetrapeptide-7 Phenoxyethanol Polysorbate 20 Pomegranate Retinol Saccharide Isomerate Sodium Hydroxide Sodium Pyrrolidone Carboxylate Tetrahexyldecyl Ascorbate Cocoa Butter .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-01

Description

Octinoxate 5.00% Octisalate 3.00% Avobenzone 3.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 5.00% Octisalate 3.00% Avobenzone 3.00%

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.

Section 51945-4

Warnings:

• For external use only.

Drug Facts

Do Not Use
  • on damaged or broken skin.
Directions:

• Apply liberally 15 minutes before sun exposure. • Reapply: - At least every two hours. - Immediately after swimming, sweating, or towel drying.





Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Limit time in the sun, especially between 10am and 2pm. - Wear long sleeve shirts, pants, hats, and sunglasses. - For children under six months, consult a physician. SUN PROTECTION MEASURES:





Active Ingredients

Octinoxate 5.00%

Octisalate 3.00%

Avobenzone 3.00%

Other Information:

• Protect this product from excessive heat and direct sunlight.

Other Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Algae Extract, C12-15 Alkyl Benzoate, Aqua (Deionized Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetearyl Alcohol, Cetearyl Glucoside, Citrus Aurantium Dulcis (Orange) Oil, Cocos Nucifera (Coconut) Oil, Ethoxydiglycol, Ethylhexylglycerin, Fucus Vesiculosus (Seaweed) Extract, Glycerin, Hyaluronic Acid, Hydrolyzed Collagen, Isopropyl Myristate, Isostearyl Palmitate, Mangifera Indica (Mango) Seed Butter, Moringa Oleifera (Moringa) Oil, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Retinol (Vitamin A), Saccharide Isomerate, Sodium Hydroxide, Sodium PCA, Tetrahexyldecyl Ascorbate (Vitamin C), Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate (Vitamin E).

When Using This Product
  • keep out of eyes.  Rinse with water to remove.
Stop Use and Consult Physician
  • if irritation  or rash develops.
Keep Out of Reach of Children. 

If product is swallowed, get medical attention or contact poison control center immediately.


Structured Label Content

Uses: (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.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings: (WARNINGS:)

• For external use only.

Drug Facts (DRUG FACTS)

Do Not Use (Do not use)
  • on damaged or broken skin.
Directions: (DIRECTIONS:)

• Apply liberally 15 minutes before sun exposure. • Reapply: - At least every two hours. - Immediately after swimming, sweating, or towel drying.





Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Limit time in the sun, especially between 10am and 2pm. - Wear long sleeve shirts, pants, hats, and sunglasses. - For children under six months, consult a physician. SUN PROTECTION MEASURES:





Active Ingredients

Octinoxate 5.00%

Octisalate 3.00%

Avobenzone 3.00%

Other Information: (OTHER INFORMATION:)

• Protect this product from excessive heat and direct sunlight.

Other Ingredients: (OTHER INGREDIENTS:)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Algae Extract, C12-15 Alkyl Benzoate, Aqua (Deionized Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetearyl Alcohol, Cetearyl Glucoside, Citrus Aurantium Dulcis (Orange) Oil, Cocos Nucifera (Coconut) Oil, Ethoxydiglycol, Ethylhexylglycerin, Fucus Vesiculosus (Seaweed) Extract, Glycerin, Hyaluronic Acid, Hydrolyzed Collagen, Isopropyl Myristate, Isostearyl Palmitate, Mangifera Indica (Mango) Seed Butter, Moringa Oleifera (Moringa) Oil, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Retinol (Vitamin A), Saccharide Isomerate, Sodium Hydroxide, Sodium PCA, Tetrahexyldecyl Ascorbate (Vitamin C), Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate (Vitamin E).

When Using This Product (When using this product)
  • keep out of eyes.  Rinse with water to remove.
Stop Use and Consult Physician (Stop use and consult physician)
  • if irritation  or rash develops.
Keep Out of Reach of Children.  (Keep out of reach of children. )

If product is swallowed, get medical attention or contact poison control center immediately.


Advanced Ingredient Data


Raw Label Data

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