Island Remedy All-day Revitalizing Moisturizer With Spf 30

Island Remedy All-day Revitalizing Moisturizer With Spf 30
SPL v3
SPL
SPL Set ID 5d139e04-244f-4f38-bea4-20e029f50f85
Route
TOPICAL
Published
Effective Date 2016-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (57.8 mg) Zinc Cation (37.4 mg)
Inactive Ingredients
Aloe Vera Leaf Water Cetearyl Isononanoate Glyceryl Monostearate Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Peg-20 Glyceryl Stearate Cetyl Palmitate Ethylhexyl Methoxycrylene Alkyl (c12-15) Benzoate Medium-chain Triglycerides Butyloctyl Salicylate Propylene Glycol Argan Oil .alpha.-tocopherol Acetate Levomenol Isostearic Acid Aluminum Hydroxide Polyhydroxystearic Acid (2300 Mw) Phenoxyethanol Caprylyl Glycol Chlorphenesin Arnica Montana Flower Chamomile Comfrey Leaf Achillea Millefolium Calendula Officinalis Flower Prunus Serotina Bark Clove Equisetum Hyemale Cymbopogon Schoenanthus Top Jojoba Oil Ascorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-05-24

Description

Titanium Dioxide 5.78% Zinc Oxide 3.74%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 5.78% Zinc Oxide 3.74%

Uses

• Helps prevent sunburn • Higher SPF gives more sunburn protection.

Warnings

For external use only

Avoid contact with eyes, rinse with water to remove.

Directions

Apply a small amount on area of skin treatment, reapply frequently if necessary.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

Package Labeling:

Inner Package Labeling:

Outer Package Labeling:

Active Ingredients

Titanium Dioxide 5.78%

Zinc Oxide 3.74%

Inactive Ingredients:

Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Water (Aqua/Eau), Cetearyl Isononanoate, Glyceryl Stearate, Cetearyl Alcohol, Ceteareth-20, PEG-20 Glyceryl Stearate, Cetyl Palmitate, Ethylhexyl Methoxycrylene, C12-C15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Hydrogen Dimethicone, Butyloctyl Salicylate, Propylene Glycol, Argania Spinosa Kernel Oil, Tocopheryl Acetate (Vitamin E Acetate), Bisabolol, Isostearic Acid, Aluminum Hydroxide, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Arnica Montana Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Symphytum Officinale Leaf Extract, Achillea Millefolium Extract, Calendula Offcinalis Flower Extract, Prunus Serotina (Wild Cherry) Bark Extract, Eugenia Caryophyllus (Clove) Flower Extract, Equisetum Hiemale Extract, Cymbopogon Schoenanthus Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Ascorbic Acid (Vitamin C).

Stop Use and Consult A Doctor

if rash or irritation develops and lasts.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

• Helps prevent sunburn • Higher SPF gives more sunburn protection.

Purpose

Sunscreen

Warnings

For external use only

Avoid contact with eyes, rinse with water to remove.

Directions

Apply a small amount on area of skin treatment, reapply frequently if necessary.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

Package Labeling:

Inner Package Labeling:

Outer Package Labeling:

Active Ingredients (Active ingredients)

Titanium Dioxide 5.78%

Zinc Oxide 3.74%

Inactive Ingredients:

Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Water (Aqua/Eau), Cetearyl Isononanoate, Glyceryl Stearate, Cetearyl Alcohol, Ceteareth-20, PEG-20 Glyceryl Stearate, Cetyl Palmitate, Ethylhexyl Methoxycrylene, C12-C15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Hydrogen Dimethicone, Butyloctyl Salicylate, Propylene Glycol, Argania Spinosa Kernel Oil, Tocopheryl Acetate (Vitamin E Acetate), Bisabolol, Isostearic Acid, Aluminum Hydroxide, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Arnica Montana Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Symphytum Officinale Leaf Extract, Achillea Millefolium Extract, Calendula Offcinalis Flower Extract, Prunus Serotina (Wild Cherry) Bark Extract, Eugenia Caryophyllus (Clove) Flower Extract, Equisetum Hiemale Extract, Cymbopogon Schoenanthus Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Ascorbic Acid (Vitamin C).

Stop Use and Consult A Doctor (Stop use and consult a doctor)

if rash or irritation develops and lasts.

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)