Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 94d604d4-b0bf-4f3e-888c-b6104241925b
Route
TOPICAL
Published
Effective Date 2017-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (85.0 mg) Titanium Dioxide (65.0 mg)
Inactive Ingredients
Cyclomethicone 5 Dimethicone Water Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Bismuth Oxychloride Butylene Glycol Hydroxypropylcocoate Peg-8 Dimethicone Polyglyceryl-2 Diisostearate Hydrated Silica Mica Stearic Acid Aluminum Hydroxide Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Jojoba Oil, Randomized Triepoxycyclohexasilane Biosaccharide Gum-1 Isohexadecane Peg/ppg-18/18 Dimethicone Glycerin Apple Vitis Vinifera Seed Mentha Piperita Menthyl Dl-pyrrolidonecarboxylate Hyaluronate Sodium Allantoin .beta.-carotene Tocopherol Adenosine Triphosphate Saccharomyces Lysate N-acetyltyrosine Vitamin A Palmitate Ascorbyl Palmitate Egg Phospholipids Proline Ethyl Menthane Carboxamide Phenoxyethanol Ethylhexylglycerin Hexylene Glycol Caprylyl Glycol Triethoxycaprylylsilane Limonene, (+)- Linalool, (+)- Citral Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-12-05

Description

Zinc Oxide 8.5% Titanium Dioxide 6.5%


Medication Information

Warnings and Precautions

For external use only.

do not use on damaged or broken skin.

when using this product keep out of eyes.

rinse with water to remove.

stop use and ask a doctor if rash occurs.

keep out of reach of children.

Indications and Usage

Uses: Helps prevent sunburn.

if used as directed with other sun protection measures, decreases the rsk of skin cancer and early skin aging caused by the sun.

post treatment camouflage for skin needling and rejuvenation procedures.

Dosage and Administration

Directions: Apply immediately after treatment procedures, to dry clean skin, as a acamouflage for minor skin trauma. Apply daily after your skincare regime with DPDermaceuticals, as a corrective sunscreen foundation.

Sun protection measures: For sunscreen use

Apply for liberally 15 minutes before sun exposure. Re-apply every 2 hours, or after swimming or drying off with a towel. Prolonged exposure to the sun should be avoided, especially from 10:00am - 2:00pm. Suitable clothing such as long-sleeved shirt, hats, and sunglasses should be worn at all times in the sun. Use on children under 6 months ask a doctor. 

Description

Zinc Oxide 8.5% Titanium Dioxide 6.5%

Section 51727-6

Cyclopentasiloxane, Dimethicone, Water (Aqua), Polyglyceryl-3-Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Bismuth Oxychloride, Butylene Glycol, Hydroxypropylcocoate PE-8 Dimethicone, Polyglyceryl-2 Diisostearate, Hydrated Silica, Mica, Stearic Acid, Aluminum Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Jojoba Esters, Cyclohexasiloxane, Biosaccharide Gum-1, Isohexadecane, PEG/PPG-18/18 Dimethicone, Glycerin, Pyrus Malus (Apple) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Mentha Piperita (Peppermint) Extract, Menthyl PCA, Sodium Hyaluronate, Copper Lysinate/Rolinate, Allantoin, Beta-Carotene, Hydrolyzed Vegetable Protein, Tocopherol, Adenosine Triphosphate, Saccharomyces Lysate Extract, Acetyl Tyrosine, Methylglucoside Phosphate, Retinyl Palmitate, Ascorbyl palmitate, Phospholipids, Proline, Ethyl menthane carboxamide, Triethoxysilylethyl Polydimethylsiloxyethyl HexylDimethicone, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Fragrance (Parfum), Triethoxycaprylysilane, Limonene, Linalool, citral, May contain:(+/-) Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Section 51945-4

DML42141/GMP Certified.

manufactured in USA for 

EQUIPMED EUROPE LONDON, W1H 1PJ

Made exclusively for www.dermapenworld.com

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 8.5%

Titanium Dioxide 6.5%

Section 60561-8

Protect the product in this container from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Uses: Helps prevent sunburn.

if used as directed with other sun protection measures, decreases the rsk of skin cancer and early skin aging caused by the sun.

post treatment camouflage for skin needling and rejuvenation procedures.

Dosage and Administration (34068-7)

Directions: Apply immediately after treatment procedures, to dry clean skin, as a acamouflage for minor skin trauma. Apply daily after your skincare regime with DPDermaceuticals, as a corrective sunscreen foundation.

Sun protection measures: For sunscreen use

Apply for liberally 15 minutes before sun exposure. Re-apply every 2 hours, or after swimming or drying off with a towel. Prolonged exposure to the sun should be avoided, especially from 10:00am - 2:00pm. Suitable clothing such as long-sleeved shirt, hats, and sunglasses should be worn at all times in the sun. Use on children under 6 months ask a doctor. 

Warnings and Precautions (34071-1)

For external use only.

do not use on damaged or broken skin.

when using this product keep out of eyes.

rinse with water to remove.

stop use and ask a doctor if rash occurs.

keep out of reach of children.

Section 51727-6 (51727-6)

Cyclopentasiloxane, Dimethicone, Water (Aqua), Polyglyceryl-3-Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Bismuth Oxychloride, Butylene Glycol, Hydroxypropylcocoate PE-8 Dimethicone, Polyglyceryl-2 Diisostearate, Hydrated Silica, Mica, Stearic Acid, Aluminum Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Jojoba Esters, Cyclohexasiloxane, Biosaccharide Gum-1, Isohexadecane, PEG/PPG-18/18 Dimethicone, Glycerin, Pyrus Malus (Apple) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Mentha Piperita (Peppermint) Extract, Menthyl PCA, Sodium Hyaluronate, Copper Lysinate/Rolinate, Allantoin, Beta-Carotene, Hydrolyzed Vegetable Protein, Tocopherol, Adenosine Triphosphate, Saccharomyces Lysate Extract, Acetyl Tyrosine, Methylglucoside Phosphate, Retinyl Palmitate, Ascorbyl palmitate, Phospholipids, Proline, Ethyl menthane carboxamide, Triethoxysilylethyl Polydimethylsiloxyethyl HexylDimethicone, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Fragrance (Parfum), Triethoxycaprylysilane, Limonene, Linalool, citral, May contain:(+/-) Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Section 51945-4 (51945-4)

DML42141/GMP Certified.

manufactured in USA for 

EQUIPMED EUROPE LONDON, W1H 1PJ

Made exclusively for www.dermapenworld.com

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 8.5%

Titanium Dioxide 6.5%

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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