SPL v1
SPL
SPL Set ID 41dc9a05-d9b6-4026-a4f6-e89bc455dd25
Route
TOPICAL
Published
Effective Date 2011-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3 mg) Meradimate (1.4 mg)
Inactive Ingredients
Water Dimethicone Polyglyceryl-4 Isostearate Cetostearyl Alcohol Polyoxyl 40 Castor Oil Hexyl Laurate .alpha.-tocopherol Acetate, D- Sodium Dehydroacetate Hyaluronate Sodium Allantoin Methylparaben Magnesium Aluminum Silicate Sodium Ascorbate Propylparaben Titanium Dioxide Diazolidinyl Urea Ferric Oxide Red Mica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2005-03-13
Description

Octinoxate (7.5%) , Meradimate (3.5%)

Medication Information

Warnings and Precautions

WARNINGS : AFOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. DISCONTINUE USE IF SIGNS OF RASH OR IRRITATION APPEAR.

Indications and Usage

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



Description

Octinoxate (7.5%) , Meradimate (3.5%)

Section 50565-1

Keep out of reach of children.

Section 51727-6

Ingredients : Purified Water , Cetearyl Alcohol (And) PEG-40 Castor Oil (And) POE-20 , Dimethicone ,Polyglyceryl-4 Isostearate ,Cyclomethicone , DEA-Ceryl  Phospate, Hexyl Laurate ,Kalaya Oil , Tocopheryl Acetate ,Cetyl Dimethicone Copolyol , Diazolidinyl Urea, Sodium Dehydroacetate ,Sodium Hyaluronate , Allantoin ,Carbomer Methylparaben, Magensium Aluminum Silicate , Sodium Ascorbate, Propylparaben, (+/-) Titanium Dioxide , Iron Oixde , Mica







Section 51945-4

 

Section 55106-9

Octinoxate (7.5%) , Meradimate (3.5%)



Structured Label Content

Indications and Usage (34067-9)

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



Warnings and Precautions (34071-1)

WARNINGS : AFOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. DISCONTINUE USE IF SIGNS OF RASH OR IRRITATION APPEAR.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Ingredients : Purified Water , Cetearyl Alcohol (And) PEG-40 Castor Oil (And) POE-20 , Dimethicone ,Polyglyceryl-4 Isostearate ,Cyclomethicone , DEA-Ceryl  Phospate, Hexyl Laurate ,Kalaya Oil , Tocopheryl Acetate ,Cetyl Dimethicone Copolyol , Diazolidinyl Urea, Sodium Dehydroacetate ,Sodium Hyaluronate , Allantoin ,Carbomer Methylparaben, Magensium Aluminum Silicate , Sodium Ascorbate, Propylparaben, (+/-) Titanium Dioxide , Iron Oixde , Mica







Section 51945-4 (51945-4)

 

Section 55106-9 (55106-9)

Octinoxate (7.5%) , Meradimate (3.5%)



Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:17.053506 · Updated: 2026-03-14T22:52:42.374916