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.

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

 

Section 55106-9

Octinoxate (7.5%) , Avobenzone (2.0%)



Structured Label Content

Indications and Usage (34067-9)

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

 

Warnings and Precautions (34071-1)

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

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)

 

Section 55106-9 (55106-9)

Octinoxate (7.5%) , Avobenzone (2.0%)



Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:25.831165 · Updated: 2026-03-14T22:53:02.283244