da68fdb7-2c02-4b28-aba3-b9bb6d203b72

SPL v1
SPL
SPL Set ID da68fdb7-2c02-4b28-aba3-b9bb6d203b72
Route
topical
Published
Effective Date 2011-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (3.75 g) avobenzone (1 g)
Inactive Ingredients
water dimethicone polyglyceryl-4 isostearate cetostearyl alcohol polyoxyl 40 castor oil hexyl laurate .alpha.-tocopherol acetate, d- hyaluronate sodium allantoin sodium ascorbate phenoxyethanol methylparaben propylparaben isopropylparaben isobutylparaben linalool, (+/-)-

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2009-03-01
Description

Octinoxate (7.5%) , Avobenzone (2.0%)

Medication Information

Warnings and Precautions

 FOR EXTERNAL USE ONLY. USE CARE DURING APPLICATION TO AVOID GETTING IN EYE. IF DISCOMFORT OR IRRITATIONDEVELOPS, WASH OFF GENTLY AND DISCONTINUE USE.

 

Active Ingredient

Octinoxate (7.5%) , Avobenzone (2.0%)



Indications and Usage


Description

Octinoxate (7.5%) , Avobenzone (2.0%)

Section 50565-1

Keep out of reach of children.

Section 51727-6

Other Ingredients : Water , Ethylhexylmethoxycinnamate , Cyclopentasiloxane , Cetearyl Alcohol ,Dimethicone , Polyglyceryl-4 Isostearate , Cetyl PEG/PPG-10/1 Dimethicone ,

Hexyl Laurate , PEG-40 Castor Oil , Dromiceius (Emu) Oil , Potassium Cetyl Phosphate ,Tocopheryl Acetate ,Polysorbate 60 , Sodium Hyaluronate ,  Allantoin ,Sodium Ascorbate , Phenoxyethanol ,Methylparaben , Tetrasodium EDTA ,Carbomer , Isopropylparaben , Isobutylparaben ,Butylpraben , Sodium Dehydroacetate , Aminomethyl Propanol ,Linalool , Propylparaben ,  Acrylates/C10-C30 Alkyl Acrylate Crosspolymer          

 







Section 51945-4

 

Structured Label Content

Warnings and Precautions (34071-1)

 FOR EXTERNAL USE ONLY. USE CARE DURING APPLICATION TO AVOID GETTING IN EYE. IF DISCOMFORT OR IRRITATIONDEVELOPS, WASH OFF GENTLY AND DISCONTINUE USE.

 

Active Ingredient (55106-9)

Octinoxate (7.5%) , Avobenzone (2.0%)



Indications and Usage (34067-9)


Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Other Ingredients : Water , Ethylhexylmethoxycinnamate , Cyclopentasiloxane , Cetearyl Alcohol ,Dimethicone , Polyglyceryl-4 Isostearate , Cetyl PEG/PPG-10/1 Dimethicone ,

Hexyl Laurate , PEG-40 Castor Oil , Dromiceius (Emu) Oil , Potassium Cetyl Phosphate ,Tocopheryl Acetate ,Polysorbate 60 , Sodium Hyaluronate ,  Allantoin ,Sodium Ascorbate , Phenoxyethanol ,Methylparaben , Tetrasodium EDTA ,Carbomer , Isopropylparaben , Isobutylparaben ,Butylpraben , Sodium Dehydroacetate , Aminomethyl Propanol ,Linalool , Propylparaben ,  Acrylates/C10-C30 Alkyl Acrylate Crosspolymer          

 







Section 51945-4 (51945-4)

 

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:26.529590 · Updated: 2026-03-14T22:53:04.035717