FDA.reportPublic FDA data

Moisturizing Antioxidant

Manufacturer
Topiderm, Inc. | Pure Source, LLC
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:34:18

Label at a glance#

ProductMoisturizing Antioxidant SPF 50
Active ingredientOCTISALATE, OCTINOXATE, OXYBENZONE, HOMOSALATE, 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 before sun exposure Re-apply after swimming, excessive perspiring, or anytime after towel drying 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 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients
Octinoxate 7.5%Sunscreen
Octisalate 5.0%Sunscreen
Homosalate 7.0%Sunscreen
Oxybenzone 5.0%Sunscreen
Zinc Oxide 6.0%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 before sun exposure

  • Re-apply after swimming, excessive perspiring, or anytime after towel drying
  • 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

Bisabolol, Caffeine, Camellia Sinensis (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetyl Phosphate, Cucumis Sativus (Cucumber) Fruit Extract, C13-14 Iso-Paraffin, Dimethicone, Disodium EDTA, Disodium Lauriminodipropionate Tocopheryl Phosphates, Ectoin, Ethylene Brassylate, Glycerin, Glyceryl Stearate, Laureth-7, PEG-12 Dimethicone, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-60, Silybum (Silymarin) Marianum Fruit Extract, Sodium Hyaluronate, Squalane, Sorbic Acid, Triethoxycaprylylsilane, Water, Xanthan Gum.

PRINCIPAL DISPLAY PANEL - 120 ml Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

DAILY

Moisturizing
Antioxidant Sunscreen
SPF 50+

Broad Spectrum SPF 50+

Net 4 fl. oz. (120 ml)

Available
Custom Branded
800.445.2595
c.service@topixpharm.com

PRINCIPAL DISPLAY PANEL - 120 ml Can Label
PRINCIPAL DISPLAY PANEL - 120 ml Can Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
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bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-879-01Moisturizing AntioxidantSPF 50120 mL in 1 CANISTERSPRAY1201

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-87951326-879-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
HOMOSALATEV06SV4M95SACTIB
ZINC OXIDESOI2LOH54ZACTIB
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
CAFFEINE3G6A5W338EIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL PHOSPHATEVT07D6X67OIACT
CUCUMBERYY7C30VXJTIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
DIMETHICONE 200RGS4T2AS00IACT
EDETATE DISODIUM7FLD91C86KIACT
DISODIUM LAURIMINODIPROPIONATEKAS63U0A87IACT
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES0K5Y9U1P6MIACT
ECTOINE7GXZ3858RYIACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LAURETH-7Z95S6G8201IACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
PEG-100 MONOSTEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
POLYSORBATE 60CAL22UVI4MIACT
MILK THISTLEU946SH95EEIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SQUALANEGW89575KF9IACT
SORBIC ACIDX045WJ989BIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT

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
Moisturizing Antioxidant SPF 50OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDETopiderm, Inc.727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f2026-01-05WarningsExact identifier
ndc (package): 51326-879-01
ndc (product): 51326-879
ndc11 (package): 51326087901
spl id: 22e498d9-1e2e-48a6-a3c6-87a0dca750a3
spl set id: 727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f

Reported adverse events (FAERS/openFDA)#

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