SPL v1
SPL
SPL Set ID 46e854cb-6694-4e57-b6e4-15684dfab80b
Route
TOPICAL
Published
Effective Date 2018-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Oxybenzone (60 mg) Octisalate (50 mg) Avobenzone (20 mg) Octocrylene (15 mg)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Octyldodecyl Neopentanoate Medium-chain Triglycerides Glycerin Hyaluronate Sodium Green Tea Leaf Teprenone Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Cyclomethicone 4 Kiwi Fruit Chlorella Vulgaris Artemisia Vulgaris Whole Saccharomyces Lysate Centella Asiatica Echinacea Purpurea Carboxypolymethylene Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Polyethylene Glycol 400 Trolamine Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Tocopherol Ascorbyl Palmitate Citric Acid Monohydrate Zinc Pidolate Mannitol Lonicera Japonica Flower Sodium Citrate Xanthium Sibiricum Fruit Aloe Vera Leaf Cyperus Rotundus Tuber Acetyl Tetrapeptide-15 Sodium Benzoate Sorbitan Monooleate Polysorbate 20 Palmitoyl Pentapeptide-4 Arctostaphylos Uva-ursi Leaf Olea Europaea Leaf Darutoside Xanthan Gum Arabidopsis Thaliana Ubidecarenone Idebenone Edetate Disodium Omega-3 Fatty Acids Vitamin A Palmitate .beta.-carotene Ascorbic Acid Apple Lecithin, Soybean

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-12-07

Description

OCTINOXATE,OXYBENZONE,OCTISALATE and AVOBENZONE


Medication Information

Description

OCTINOXATE,OXYBENZONE,OCTISALATE and AVOBENZONE

Actives

OCTINOXATE,OXYBENZONE,OCTISALATE and AVOBENZONE

Inactives

Water (Aqua)

C12-15 Alkyl Benzoate

Octinoxate

Oxybenzone

Octisalate

Butylene Glycol

Octyldodecyl Neopentanoate

Caprylic/Capric Triglyceride

Avobenzone

Octocrylene

Glycerin

Sodium Hyaluronate

Camellia Sinensis Leaf Extract

Teprenone

Cyclopentasiloxane

Cyclohexasiloxane

Actinidia Chinensis (Kiwi) Fruit Extract

Algae Extract

Artemisia Vulgaris Extract

Saccharomyces Lysate Extract

Centella Asiatica Extract

Echinacea Purpurea Extract

Yeast Polysaccharides

Carbomer

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

PEG-8

Triethanolamine

Phenoxyethanol

Caprylyl Glycol

Ethylhexylglycerin

Hexylene Glycol

Tocopherol

Ascorbyl Palmitate

Citric Acid

Zinc PCA

Mannitol

Lonicera Japonica (Honeysuckle) Flower Extract

Sodium Citrate

Xanthium Sibiricum Fruit Extract

Aloe Barbadensis Leaf Extract

Cyperus Rotundus Root Extract

Acetyl Tetrapeptide-15

Sodium Benzoate

Sorbitan Oleate

Polysorbate 20

Palmitoyl Pentapeptide-4

Arctostaphylos Uva Ursi Leaf Extract

Plankton Extract

Mitracarpus Scaber Extract

Olea Europaea (Olive) Leaf  Extract

Darutoside

Xanthan Gum

Micrococcus Lysate

Arabidopsis Thaliana Extract

Ubiquinone

Hydroxydecyl Ubiquinone

Disodium EDTA

Phospholipids

Retinyl Palmitate

Beta-Carotene

Ascorbic Acid

Malus Domestica Fruit Cell Culture Extract

Lecithin

Tube Label 

Tube Label 2


Structured Label Content

Actives

OCTINOXATE,OXYBENZONE,OCTISALATE and AVOBENZONE

Inactives

Water (Aqua)

C12-15 Alkyl Benzoate

Octinoxate

Oxybenzone

Octisalate

Butylene Glycol

Octyldodecyl Neopentanoate

Caprylic/Capric Triglyceride

Avobenzone

Octocrylene

Glycerin

Sodium Hyaluronate

Camellia Sinensis Leaf Extract

Teprenone

Cyclopentasiloxane

Cyclohexasiloxane

Actinidia Chinensis (Kiwi) Fruit Extract

Algae Extract

Artemisia Vulgaris Extract

Saccharomyces Lysate Extract

Centella Asiatica Extract

Echinacea Purpurea Extract

Yeast Polysaccharides

Carbomer

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

PEG-8

Triethanolamine

Phenoxyethanol

Caprylyl Glycol

Ethylhexylglycerin

Hexylene Glycol

Tocopherol

Ascorbyl Palmitate

Citric Acid

Zinc PCA

Mannitol

Lonicera Japonica (Honeysuckle) Flower Extract

Sodium Citrate

Xanthium Sibiricum Fruit Extract

Aloe Barbadensis Leaf Extract

Cyperus Rotundus Root Extract

Acetyl Tetrapeptide-15

Sodium Benzoate

Sorbitan Oleate

Polysorbate 20

Palmitoyl Pentapeptide-4

Arctostaphylos Uva Ursi Leaf Extract

Plankton Extract

Mitracarpus Scaber Extract

Olea Europaea (Olive) Leaf  Extract

Darutoside

Xanthan Gum

Micrococcus Lysate

Arabidopsis Thaliana Extract

Ubiquinone

Hydroxydecyl Ubiquinone

Disodium EDTA

Phospholipids

Retinyl Palmitate

Beta-Carotene

Ascorbic Acid

Malus Domestica Fruit Cell Culture Extract

Lecithin

Tube Label 

Tube Label 2 (Tube label 2)


Advanced Ingredient Data


Raw Label Data

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