ce3d8fa7-56bb-40bb-ae05-e5bb687ddf7d

SPL v1
SPL
SPL Set ID ce3d8fa7-56bb-40bb-ae05-e5bb687ddf7d
Route
topical
Published
Effective Date 2011-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (3 mL) avobenzone (0.8 mL)
Inactive Ingredients
water dimethicone cyclomethicone 5 polyglyceryl-4 isostearate cetostearyl alcohol hexyl laurate .alpha.-tocopherol acetate, d- sodium dehydroacetate hyaluronate sodium allantoin sodium ascorbate polysorbate 60 phenoxyethanol methylparaben propylparaben butylparaben isopropylparaben isobutylparaben aminomethylpropanol linalool, (+/-)-

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2010-11-29

Description

Octinoxate (7.5%) , Avobenzone (2.0%)


Medication Information

Warnings and Precautions

WARNINGS : FOR EXTERNAL USE ONLY.AVOID CONTACT WITH EYES. IF CONTACT OCCURS. RINSE THOROUGH WITH WATER.

Active Ingredient

Octinoxate (7.5%) , Avobenzone (2.0%)



Indications and Usage

Direction for use : Apply to clean skin with fingertips. Layer for additional coverage.

 

Description

Octinoxate (7.5%) , Avobenzone (2.0%)

Section 50565-1

Keep out of reach of children.

Section 51727-6

Other Ingredients : Water ,Cetearyl Alcohol , PEG-40 Castor Oil ,Dimethicone , Polyglyceryl-4 Isostearate , Cyclomethicone , Potassium Cetyl Phosphate , Hexyl Laurate , Dromiceius Oil ,Tocopheryl Acetate ,Cetyl PEG/PPG-10/1 Dimethicone ,Polysorbate 60 ,Hydrogenated Polyisobutene , PEG-15 Cocamine , Phenoxyethanol ,Sodium Dehydroacetate ,Sodium Hyaluronate ,Allantoin ,Carbomer ,

 Aminomethyl Propanol ,  Methylparaben ,Magenesium Aluminu Silicate, Sodium Ascorbate , Isopropylparaben , Isobutylparaben , Butylpraben ,Propylparaben ,

(+/-) : CI 77891 ( Titanium Dioxide ) , CI 77492 ( Iron Oxide) , CI 77491 (Iron Oxide) , CI 77499 (Iron Oxide) , CI 77019 ( Mica )





Section 51945-4

 


Structured Label Content

Warnings and Precautions (34071-1)

WARNINGS : FOR EXTERNAL USE ONLY.AVOID CONTACT WITH EYES. IF CONTACT OCCURS. RINSE THOROUGH WITH WATER.

Active Ingredient (55106-9)

Octinoxate (7.5%) , Avobenzone (2.0%)



Indications and Usage (34067-9)

Direction for use : Apply to clean skin with fingertips. Layer for additional coverage.

 

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Other Ingredients : Water ,Cetearyl Alcohol , PEG-40 Castor Oil ,Dimethicone , Polyglyceryl-4 Isostearate , Cyclomethicone , Potassium Cetyl Phosphate , Hexyl Laurate , Dromiceius Oil ,Tocopheryl Acetate ,Cetyl PEG/PPG-10/1 Dimethicone ,Polysorbate 60 ,Hydrogenated Polyisobutene , PEG-15 Cocamine , Phenoxyethanol ,Sodium Dehydroacetate ,Sodium Hyaluronate ,Allantoin ,Carbomer ,

 Aminomethyl Propanol ,  Methylparaben ,Magenesium Aluminu Silicate, Sodium Ascorbate , Isopropylparaben , Isobutylparaben , Butylpraben ,Propylparaben ,

(+/-) : CI 77891 ( Titanium Dioxide ) , CI 77492 ( Iron Oxide) , CI 77491 (Iron Oxide) , CI 77499 (Iron Oxide) , CI 77019 ( Mica )





Section 51945-4 (51945-4)

 


Advanced Ingredient Data


Raw Label Data

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