skinuva®

skinuva®
SPL v4
SPL
SPL Set ID 5fcad8c3-a268-4966-b0a9-6cd2c7afd3b7
Route
topical
Published
Effective Date 2024-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (0.1 g)
Inactive Ingredients
water dimethicone, unspecified cyclomethicone 5 butylene glycol glycerin diethylhexyl 2,6-naphthalate dimethicone/peg-10/15 crosspolymer tetrahexyldecyl ascorbate centella asiatica triterpenoids diphenylsiloxy phenyl trimethicone dimethicone/phenyl vinyl dimethicone crosspolymer ethylhexylglycerin sodium chloride lauryl peg-9 polydimethylsiloxyethyl dimethicone hyaluronate sodium aloe vera leaf basic fibroblast growth factor (human) tocopherol phenoxyethanol interleukin-10

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-06-30

Description

Drug Facts


Medication Information

Warnings

For external use only.

Uses

Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Directions

Make sure the affected area is clean and dry. Apply a thin film over the affected area twice a day, morning and night. Wait 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. See insert for detailed instructions.

Other Information

Do not use if inner seal is broken. Store at room temperature. Avoid excessive heat.

Inactive Ingredients

Water/Aqua, Dimethicone, Dimethiconol, Cyclopentasiloxane, Dimethicone Crosspolymer, Butylene Glycol, Glycerin, Diethylhexyl 2,6-Naphthalate, Dimethicone/PEG-10/15 Crosspolymer, Tetrahexyldecyl Ascorbate, Centella Asiatica Extract, Diphenylsiloxy Phenyl Trimethicone, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Ethylhexylglycerin, Sodium Chloride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, sh-Polypeptide-1, Tocopherol, sh-Polypeptide-6, sh-Polypeptide-5

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if rash or irritation occurs.

Section 50567-7

When using this product keep out of eyes. If contact occurs, rinse eyes thoroughly with plenty of water to remove. If swallowed immediately seek medical advice and show container or label.

Section 50570-1

Do not use on damaged/broken skin or open wounds.

Section 55105-1
Active ingredients Purpose
Data on file
Zinc Oxide 10% Sunscreen
Dosage Form Cream
Principal Display Panel 30 Ml Bottle Carton

NDC: 82350-352-30

SKINUVA®

scar+

BROAD SPECTRUM SPF 30

Scar photoaging defense cream using

highly selective growth factors with

Zinc Oxide mineral sunscreen

Developed and tested

by physicians

30 mL / 1 fl. oz e


Structured Label Content

Warnings

For external use only.

Uses

Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Directions

Make sure the affected area is clean and dry. Apply a thin film over the affected area twice a day, morning and night. Wait 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. See insert for detailed instructions.

Other Information (Other information)

Do not use if inner seal is broken. Store at room temperature. Avoid excessive heat.

Inactive Ingredients (Inactive ingredients)

Water/Aqua, Dimethicone, Dimethiconol, Cyclopentasiloxane, Dimethicone Crosspolymer, Butylene Glycol, Glycerin, Diethylhexyl 2,6-Naphthalate, Dimethicone/PEG-10/15 Crosspolymer, Tetrahexyldecyl Ascorbate, Centella Asiatica Extract, Diphenylsiloxy Phenyl Trimethicone, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Ethylhexylglycerin, Sodium Chloride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, sh-Polypeptide-1, Tocopherol, sh-Polypeptide-6, sh-Polypeptide-5

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash or irritation occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. If contact occurs, rinse eyes thoroughly with plenty of water to remove. If swallowed immediately seek medical advice and show container or label.

Section 50570-1 (50570-1)

Do not use on damaged/broken skin or open wounds.

Section 55105-1 (55105-1)
Active ingredients Purpose
Data on file
Zinc Oxide 10% Sunscreen
Dosage Form Cream
Principal Display Panel 30 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton)

NDC: 82350-352-30

SKINUVA®

scar+

BROAD SPECTRUM SPF 30

Scar photoaging defense cream using

highly selective growth factors with

Zinc Oxide mineral sunscreen

Developed and tested

by physicians

30 mL / 1 fl. oz e


Advanced Ingredient Data


Raw Label Data

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