Antioxidant Sunscreen SPF 40

Manufacturer
Topiderm, Inc. | Topix Pharmaceuticals, Inc.
Effective date
2019-11-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:59:31

Label at a glance#

ProductAntioxidant Sunscreen SPF 40
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure Re-apply after 80 minutes of swimming or sweating, anytime after towel drying, or at least every 2 hours Use a water resistant sunscreen if swimming or sweating Use on children under 6 months of age: consult a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscr...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Octinoxate 7.5%Sunscreen
Zinc Oxide 7.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product keep out of eyes, rinse with water to remove.

OTC - STOP USE SECTION

Stop use if signs of irritation or rash appear.If irritation or rash persists consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Re-apply after 80 minutes of swimming or sweating, anytime after towel drying, or at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Use on children under 6 months of age: consult a doctor.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sunscreen measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ascorbic Acid, Ascorbyl Palmitate, Butylene Glycol, Camellia Sinensis (Green Tea) Leaf Extract, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Ceresin, Chitosan, Cyclomethicone, Diazolidinyl Urea, Disodium EDTA, Laureth-7, Lauryl PEG/PPG-18/18 Methicone, Methylparaben, Phospholipids, Polyacrylamide, Propyl Gallate, Propylene Glycol, Propylparaben, Purified Water, Retinyl Palmitate, Sodium Chloride, Superdioxide Dismutase, Tocopheryl Acetate, Ubiquinone (Co Q-10).

PRINCIPAL DISPLAY PANEL - 105 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CITRIX®

VITAMIN C
ANTIOXIDANT SUNSCREEN
BROAD SPECTRUM SPF 40

UVA & UVB Protection
Micronized Zinc Oxide
Water Resistant (80 minutes)

POLYMER MATRIX TECHNOLOGY

Net 3.5 fl. oz. (105 ml)
Topix Pharmaceuticals, Inc. | N. Amityville, NY 11701

PRINCIPAL DISPLAY PANEL - 105 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 105 ml Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-829-03Antioxidant Sunscreen SPF 40105 mL in 1 BOTTLE, PLASTICLOTION1056

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-829ANTIOXIDANT SUNSCREEN SPF 40 (OCTINOXATE AND ZINC OXIDE) LOTION [TOPIDERM, INC.]6Current NDC, Legacy NDC, 1 package rows20231109_2686378c-8827-47fb-b3ed-07438bd4e9e2.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-82951326-829-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antioxidant Sunscreen SPF 40OCTINOXATE AND ZINC OXIDETopiderm, Inc.2686378c-8827-47fb-b3ed-07438bd4e9e22019-11-13WarningsExact identifier
ndc (package): 51326-829-03
ndc (product): 51326-829
ndc11 (package): 51326082903
spl id: 1e23a07e-f101-477a-98ab-51df88e50464
spl set id: 2686378c-8827-47fb-b3ed-07438bd4e9e2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.