SPL v2
SPL
SPL Set ID 23bffdce-39e4-d6b5-e063-6394a90a5b9b
Route
TOPICAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aloe Vera Leaf (0.3 mg) Rosemary Hyaluronic Acid Niacinamide Avocado Oil
Inactive Ingredients
Tetrasodium Edetate Dihydrate Phenoxyethanol Vitamin E Polyethylene Glycol Succinate Glycerin Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-01

Description

Niacinamide 83 Serum helps to protect the skin's immune function as well as improve signs of sun damage, dryness and roughness.


Medication Information

Warnings and Precautions

Directions: Apply a small amount twice daily to the affected area. Make sure skin is clean and dry. Gently massage until completely absorbed.

Indications and Usage

Apply a small amount twice daily to the affected area. Make sure skin is clean and dry. Gently massage until completely absorbed.

Dosage and Administration

Niacinamide 83 Serum helps to protect the skin's immune function as well as improve signs of sun damage, dryness and roughness.

Description

Niacinamide 83 Serum helps to protect the skin's immune function as well as improve signs of sun damage, dryness and roughness.

Section 50565-1

keep out of reach of children

Section 51727-6

Inactive ingredients: Glycerin, Emulsifying Wax NF, Phenoxyethanol, Xanthan Gum, Tetrasodium EDTA.

Section 51945-4

Content of labeling

Section 55105-1

natural + organic Niacinamide B3 facial serum

Niacinamide 83 Reduces Water Loss in the Skin and Retains Fatty Acid Levels for a Younger, Plumper and Firmer Skin.

Distributed By: Skin Beauty Solutions Elk Grove CA 95759

Section 55106-9

Active ingredients: Aloe Vera Leaf Juice, Niacinamide (Vitamin B3), Avocado Oil, Vitamin E, Organic Neem Seed Oil, Rosemary Leaf Extract, Hyaluronic Acid.


Structured Label Content

Indications and Usage (34067-9)

Apply a small amount twice daily to the affected area. Make sure skin is clean and dry. Gently massage until completely absorbed.

Dosage and Administration (34068-7)

Niacinamide 83 Serum helps to protect the skin's immune function as well as improve signs of sun damage, dryness and roughness.

Warnings and Precautions (34071-1)

Directions: Apply a small amount twice daily to the affected area. Make sure skin is clean and dry. Gently massage until completely absorbed.

Section 50565-1 (50565-1)

keep out of reach of children

Section 51727-6 (51727-6)

Inactive ingredients: Glycerin, Emulsifying Wax NF, Phenoxyethanol, Xanthan Gum, Tetrasodium EDTA.

Section 51945-4 (51945-4)

Content of labeling

Section 55105-1 (55105-1)

natural + organic Niacinamide B3 facial serum

Niacinamide 83 Reduces Water Loss in the Skin and Retains Fatty Acid Levels for a Younger, Plumper and Firmer Skin.

Distributed By: Skin Beauty Solutions Elk Grove CA 95759

Section 55106-9 (55106-9)

Active ingredients: Aloe Vera Leaf Juice, Niacinamide (Vitamin B3), Avocado Oil, Vitamin E, Organic Neem Seed Oil, Rosemary Leaf Extract, Hyaluronic Acid.


Advanced Ingredient Data


Raw Label Data

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