truth revealed super creme with spf 15

truth revealed super creme with spf 15
SPL v11
SPL
SPL Set ID e08e0173-9c06-45ff-a884-b89429e91390
Route
topical
Published
Effective Date 2013-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (7.5 g) avobenzone (2 g) oxybenzone (1.9 g) octocrylene
Inactive Ingredients
water glycerin aloe vera leaf cetostearyl alcohol glyceryl monostearate peg-100 stearate dimethicone palmitoyl tripeptide-5 pullulan chondrus crispus plukenetia volubilis seed oil tetrahexyldecyl ascorbate calcium ascorbate chamomile carrot avena sativa leaf vaccinium myrtillus leaf sucrose acer saccharum bark/sap orange lemon levomenol allantoin alpha-tocopherol acetate carbomer 934 polyoxyl 20 cetostearyl ether aminomethylpropanol phytic acid citric acid monohydrate phenoxyethanol ethylhexylglycerin potassium sorbate

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2010-08-15

Description

Active Ingredient                Purpose Octinoxate  7.5%               Sunscreen Avobenzone 2.0%              Sunscreen Oxybenzone 2.0%              Sunscreen Octocrylene 1.9%               Sunscreen


Medication Information

Warnings and Precautions

Warnings

For external use only

When using this product keep out of eyes. Rinse with water to remove.

If swallowed, get immediate medical help or contact a poison control center right away.

Active Ingredient

Active Ingredient                Purpose

Octinoxate  7.5%               Sunscreen

Avobenzone 2.0%              Sunscreen

Oxybenzone 2.0%              Sunscreen

Octocrylene 1.9%               Sunscreen

Indications and Usage

Stop use and ask a doctor if rash or irritation develops and lasts

Dosage and Administration

Directions

Massage into skin in upward motion, outward circular motions

For children under 6 months, ask a doctor.

Description

Active Ingredient                Purpose Octinoxate  7.5%               Sunscreen Avobenzone 2.0%              Sunscreen Oxybenzone 2.0%              Sunscreen Octocrylene 1.9%               Sunscreen

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive Ingredients

Water (Aqua,Eau), cocoglycerides, Glycerin, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Palmitoyl Tripeptide-5, Algae Extract, Pullulan, Chondrus Chrispus (Carrageenan), Plukenetia Volubilis Seed Oil, Schinus Terebinthifolius Seed Extract, Tetrahexyldecyl Ascorbate, calcium Ascorbate, Sodium Hyaluronate, Chamomilla Recutita (Matricaria) Flower Extract, Daucus Carota Sativa (Carrot) Extract, Corylus Avellana (Hazelnut) extract, Avena Sativa (Oat) Meal Extract. Vaccinum Myrtillus Extract, Saccharum Officinarum (Sugar Cane) Extract, Acer Saccharinum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Medica Limonium (Lemon) Fruit Extract, Bisabolol, Allantoin, Tocopheryl Acetate, Carbomer, Ceteareth-20, Aminomethyl Propanol, sodium Phytate, Citric Acid, Polyacrylate-13/polyisobutene/polysorbate 20, Phenoxy ethanol, Ethylhexylglycerin, Potassium Sorbate, Fragrance (Parfum)

Section 51945-4

Ole Henriksen

All skin types/anti-aging

Truth Revealed Super Creme with SPF 15

Net. Wt. 1.7 oz/ 50g

Section 55105-1

Uses:

Helps prevent sunburn.

Higher SPF gives more sunburn protection.


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

When using this product keep out of eyes. Rinse with water to remove.

If swallowed, get immediate medical help or contact a poison control center right away.

Active Ingredient (55106-9)

Active Ingredient                Purpose

Octinoxate  7.5%               Sunscreen

Avobenzone 2.0%              Sunscreen

Oxybenzone 2.0%              Sunscreen

Octocrylene 1.9%               Sunscreen

Indications and Usage (34067-9)

Stop use and ask a doctor if rash or irritation develops and lasts

Dosage and Administration (34068-7)

Directions

Massage into skin in upward motion, outward circular motions

For children under 6 months, ask a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive Ingredients

Water (Aqua,Eau), cocoglycerides, Glycerin, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Palmitoyl Tripeptide-5, Algae Extract, Pullulan, Chondrus Chrispus (Carrageenan), Plukenetia Volubilis Seed Oil, Schinus Terebinthifolius Seed Extract, Tetrahexyldecyl Ascorbate, calcium Ascorbate, Sodium Hyaluronate, Chamomilla Recutita (Matricaria) Flower Extract, Daucus Carota Sativa (Carrot) Extract, Corylus Avellana (Hazelnut) extract, Avena Sativa (Oat) Meal Extract. Vaccinum Myrtillus Extract, Saccharum Officinarum (Sugar Cane) Extract, Acer Saccharinum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Medica Limonium (Lemon) Fruit Extract, Bisabolol, Allantoin, Tocopheryl Acetate, Carbomer, Ceteareth-20, Aminomethyl Propanol, sodium Phytate, Citric Acid, Polyacrylate-13/polyisobutene/polysorbate 20, Phenoxy ethanol, Ethylhexylglycerin, Potassium Sorbate, Fragrance (Parfum)

Section 51945-4 (51945-4)

Ole Henriksen

All skin types/anti-aging

Truth Revealed Super Creme with SPF 15

Net. Wt. 1.7 oz/ 50g

Section 55105-1 (55105-1)

Uses:

Helps prevent sunburn.

Higher SPF gives more sunburn protection.


Advanced Ingredient Data


Raw Label Data

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