SPL v1
SPL
SPL Set ID 604f72ee-ba5a-4d36-9e29-bb78e4977e0c
Route
TOPICAL
Published
Effective Date 2012-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxybenzone (1.16 mL) Avobenzone (0.58 mL) Octisalate (1.45 mL) Homosalate (2.9 mL) Octocrylene
Inactive Ingredients
Water Butylene Glycol C12-15 Alkyl Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-03-01

Description

Active Ingredients ; HOMOSALATE (10% w/w) ,OCTISALATE(5% w/w),OXYBENZONE(4%w/w), OCOCRYLENE (2% w/w), AVOBENZONE(2% w/w)


Medication Information

Warnings and Precautions


Warnings; For external use only. Not to be swalloed. Avoid contact with the eyes. Discontinue use if signs of irritation or rash appear.





Indications and Usage

Indication; Broad-spectrum UVA/UVB protection.

Description

Active Ingredients ; HOMOSALATE (10% w/w) ,OCTISALATE(5% w/w),OXYBENZONE(4%w/w), OCOCRYLENE (2% w/w), AVOBENZONE(2% w/w)

Section 50565-1

Keep out of reach of children. Do not stay too long in the sun, even while using a sunscreen product.

Section 51727-6

Water,Dimethicone, Butylene Glycol,Styrene/Acrylates Copolymer,C12-15 Alkyl Benzoate,Dicapryl Carbonate,Glycerin,Ceteareth-25,Dimethicone Crosspolymer,Magnesium Aluminum Silicate, Acetyl Dipeptide-1,Cetyl Ester, Plankton Extract,Hydrolyzed Algin, Adenosin, Pentylene Glycol , Tocopheryl Acetate,Crithmum Marithimum Extract,Ascorbic Acid,Hydrogenated Lecithin,Hydroxyethylcellulose,Dipropylene Glycol,Dibenzoate Acrylate / C12-22 Alkyl Methacrylate Crosspolymer ,Disodium Ethylene Dicocamide PEG-15 Disulfate,Sorbic Acid ,Caprylyl Glycol, PPG-15 Stearyl Ether Benzoate,Propylene Glycol , Xanthan Gum, Cyclopentasiloxane, PEG-75,PEG-150,PEG-6 Cetyl Dimethicone,PEG-4 Laurate,Laureth-3 ,Disodium EDTA , Ammonium Hydroxide,Iodopropyl Butylcarbamate,Methylparaben,Phenoxyethanol

Section 51945-4

 

Section 55106-9


Active Ingredients ; HOMOSALATE (10% w/w) ,OCTISALATE(5% w/w),OXYBENZONE(4%w/w), OCOCRYLENE (2% w/w), AVOBENZONE(2% w/w)




Structured Label Content

Indications and Usage (34067-9)

Indication; Broad-spectrum UVA/UVB protection.

Warnings and Precautions (34071-1)


Warnings; For external use only. Not to be swalloed. Avoid contact with the eyes. Discontinue use if signs of irritation or rash appear.





Section 50565-1 (50565-1)

Keep out of reach of children. Do not stay too long in the sun, even while using a sunscreen product.

Section 51727-6 (51727-6)

Water,Dimethicone, Butylene Glycol,Styrene/Acrylates Copolymer,C12-15 Alkyl Benzoate,Dicapryl Carbonate,Glycerin,Ceteareth-25,Dimethicone Crosspolymer,Magnesium Aluminum Silicate, Acetyl Dipeptide-1,Cetyl Ester, Plankton Extract,Hydrolyzed Algin, Adenosin, Pentylene Glycol , Tocopheryl Acetate,Crithmum Marithimum Extract,Ascorbic Acid,Hydrogenated Lecithin,Hydroxyethylcellulose,Dipropylene Glycol,Dibenzoate Acrylate / C12-22 Alkyl Methacrylate Crosspolymer ,Disodium Ethylene Dicocamide PEG-15 Disulfate,Sorbic Acid ,Caprylyl Glycol, PPG-15 Stearyl Ether Benzoate,Propylene Glycol , Xanthan Gum, Cyclopentasiloxane, PEG-75,PEG-150,PEG-6 Cetyl Dimethicone,PEG-4 Laurate,Laureth-3 ,Disodium EDTA , Ammonium Hydroxide,Iodopropyl Butylcarbamate,Methylparaben,Phenoxyethanol

Section 51945-4 (51945-4)

 

Section 55106-9 (55106-9)


Active Ingredients ; HOMOSALATE (10% w/w) ,OCTISALATE(5% w/w),OXYBENZONE(4%w/w), OCOCRYLENE (2% w/w), AVOBENZONE(2% w/w)




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)