SPL v2
SPL
SPL Set ID 23d47d29-76c1-9c05-e063-6394a90acd24
Route
TOPICAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hyaluronic Acid (0.3 mg) Glycolic Acid Lactic Acid Niacinamide Kojic Acid Alpha-arbutin Ascorbic Acid
Inactive Ingredients
Glycerin Tetrasodium Glutamate Diacetate Propylene Glycol Diacetate Ascorbic Acid Coconut Oil Xanthan Gum Phenoxyethanol Phenylalanine Stearic Acid .alpha.-tocopherol Acetate, D- Water

Identifiers & Packaging

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

Description

Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.


Medication Information

Warnings and Precautions

Directions: Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

Indications and Usage

Directions: Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

Dosage and Administration

Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

Description

Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

Section 50565-1

keep out of reach of children

Section 51727-6

Inactive ingredients: Water, Organic Coconut Oil, Grapeseed Oil, Emulsifying Wax, Stearic Acid, Glycerin, Xanthan Gum, Propylene Glycol, Undecylenoyl Phenylalanine, Phenoxyethanol, Tetrasodium Glutamate Diacetate.

Section 51945-4

Content of labeling

Section 55105-1

Pro Strength Treatment

Skin White

Fade & Remove Dark Spots, Melasma, Acne Scars, & More

Formulated with Kojic Acid, Alpha Arbutin, Lactic Acid, Glycolic Acid, Ferulic Acid, Vitamin B3 + C + E

Distributed By: Skin Beauty Solutions Elk Grove CA 95759

MADE NUSA

Section 55106-9

Active ingredients: Magnesium Ascorbyl Phosphate, Niacinamide B3, Glycolic Acid, Lactic Acid, Hyaluronic Acid, Kojic Acid, Alpha Arbutin, Hydrolyzed Oat Protein, Ethyl Ascorbic Acid, DL-Alpha Tocopherol (Vitamin E).


Structured Label Content

Indications and Usage (34067-9)

Directions: Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

Dosage and Administration (34068-7)

Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

Warnings and Precautions (34071-1)

Directions: Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the 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: Water, Organic Coconut Oil, Grapeseed Oil, Emulsifying Wax, Stearic Acid, Glycerin, Xanthan Gum, Propylene Glycol, Undecylenoyl Phenylalanine, Phenoxyethanol, Tetrasodium Glutamate Diacetate.

Section 51945-4 (51945-4)

Content of labeling

Section 55105-1 (55105-1)

Pro Strength Treatment

Skin White

Fade & Remove Dark Spots, Melasma, Acne Scars, & More

Formulated with Kojic Acid, Alpha Arbutin, Lactic Acid, Glycolic Acid, Ferulic Acid, Vitamin B3 + C + E

Distributed By: Skin Beauty Solutions Elk Grove CA 95759

MADE NUSA

Section 55106-9 (55106-9)

Active ingredients: Magnesium Ascorbyl Phosphate, Niacinamide B3, Glycolic Acid, Lactic Acid, Hyaluronic Acid, Kojic Acid, Alpha Arbutin, Hydrolyzed Oat Protein, Ethyl Ascorbic Acid, DL-Alpha Tocopherol (Vitamin E).


Advanced Ingredient Data


Raw Label Data

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