Hydropeptide Solar Defense Hand Guard

Hydropeptide Solar Defense Hand Guard
SPL v1
SPL
SPL Set ID 1002ce35-e8ac-470f-8818-328a8068ccb1
Route
TOPICAL
Published
Effective Date 2021-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (12.5 mg) Zinc Cation (25 mg)
Inactive Ingredients
Aluminum Oxide Butylene Glycol Shea Butter Alkyl (c12-15) Benzoate Caprylyl Glycol Caprylyl Trisiloxane Carbomer Homopolymer, Unspecified Type Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Cetyl Alcohol Chamomile Chlorphenesin Chondrus Crispus Carrageenan Cyclomethicone 6 Cyclomethicone 5 Anhydrous Dextrose Glycerin Glyceryl Caprylate Glyceryl Monostearate Glyceryl 1-undecylenate Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Hydrolyzed Wheat Protein (enzymatic; 3000 Mw) Isopropyl Myristate Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Niacinamide Peg-100 Stearate Phenoxyethanol Sodium Pyrrolidone Carboxylate Stearyl Alcohol .alpha.-tocopherol Acetate Trolamine Triethoxycaprylylsilane Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Prezatide Tripeptide-10 Citrulline Grape Seed Oil Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-01-01

Description

Titanium Dioxide 1.25%, Zinc Oxide 2.5%.

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 1.25%, Zinc Oxide 2.5%.

Uses

• Helps prevent sunburn.

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Directions

• Apply liberally and evenly 15 minutes before sun exposure.

• Reapply at least every 2 hours.

• Use a water-resistant sunscreen if swimming or sweating.

• Children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin.

Package Labeling:

Active Ingredients

Titanium Dioxide 1.25%, Zinc Oxide 2.5%.

Inactive Ingredients

Alumina, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylyl Glycol, Caprylyl Methicone, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Chondrus Crispus (Carrageenan),  Cyclohexasiloxane, Cyclopentasiloxane, Glucose, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Hydrolyzed Soy Protein, Hydrolyzed Wheat Protein, Isopropyl Myristate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Lecithin, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Polyhydroxystearic Acid, Pseudoalteromonas Ferment Extract, Sodium PCA, Stearyl Alcohol, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsilozyethyl Hexyl Dimethicone, Tripeptide-1, Tripeptide-10 Citrulline, Vitis Vinifera (Grape) Seed Oil, Water (Aqua), Xanthan Gum

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.

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

• Helps prevent sunburn.

Purpose

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Directions

• Apply liberally and evenly 15 minutes before sun exposure.

• Reapply at least every 2 hours.

• Use a water-resistant sunscreen if swimming or sweating.

• Children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin.

Package Labeling:

Active Ingredients

Titanium Dioxide 1.25%, Zinc Oxide 2.5%.

Inactive Ingredients

Alumina, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylyl Glycol, Caprylyl Methicone, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Chondrus Crispus (Carrageenan),  Cyclohexasiloxane, Cyclopentasiloxane, Glucose, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Hydrolyzed Soy Protein, Hydrolyzed Wheat Protein, Isopropyl Myristate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Lecithin, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Polyhydroxystearic Acid, Pseudoalteromonas Ferment Extract, Sodium PCA, Stearyl Alcohol, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsilozyethyl Hexyl Dimethicone, Tripeptide-1, Tripeptide-10 Citrulline, Vitis Vinifera (Grape) Seed Oil, Water (Aqua), Xanthan Gum

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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