FDA.reportPublic FDA data

Essential Moisturizing Sunscreen

Manufacturer
Topiderm, Inc.
Effective date
2023-02-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:27:42

Label at a glance#

ProductEssential Moisturizing Sunscreen
Active ingredientZINC OXIDE, OCTINOXATE
Label structure8 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 to face and neck and spread evenly 15 minutes 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Zinc Oxide 14.8%Sunscreen
Octinoxate 7.5%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.

Sun Protection Measures

SPL UNCLASSIFIED SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally to face and neck and spread evenly 15 minutes 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Diethylhexyl Succinate, Octyldodecyl Neopentanoate, Cetearyl Glucoside, Cetyl Ethylhexanoate, Polyisobutene, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Xanthan Gum, Butylene Glycol, Triethoxycaprylylsilane, Oleth-3 Phosphate, Ethylhexyl Stearate, Dimethicone, Sucrose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-7 Trimethylolpropane Coconut Ether, Panthenol, Phenoxyethanol, Disodium EDTA.

PRINCIPAL DISPLAY PANEL - 63 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REPLENiX®
SUNSCREEN

ESSENTIAL
MOISTURIZING
SPF 50

14.8% Micronized Zinc Oxide
Hydrating Hyaluronic Acid
Quick-absorbing Application

BROAD SPECTRUM UVA/UVB SPF 50

Net wt. 2.22 oz. (63 g)

TOPIX PHARMACEUTICALS, INC. N. AMITYVILLE, NY 11701

PRINCIPAL DISPLAY PANEL - 63 g Bottle Label
PRINCIPAL DISPLAY PANEL - 63 g Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-122-20Essential Moisturizing Sunscreen63 g in 1 BOTTLE, PLASTICLOTION634

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-122ESSENTIAL MOISTURIZING SUNSCREEN (ZINC OXIDE, OCTINOXATE) LOTION [TOPIDERM, INC.]4Current NDC, 1 package rows20241022_450d916e-4c77-489e-86b1-78b686355476.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-12251326-122-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT
DIETHYLHEXYL SUCCINATE69W9UMG3P8IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETYL ETHYLHEXANOATE134647WMX4IACT
POLYISOBUTYLENE (2300 MW)DSQ2V1DD1KIACT
HYALURONATE SODIUMYSE9PPT4THIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAFFEINE3G6A5W338EIACT
XANTHAN GUMTTV12P4NEEIACT
1,3-BUTANEDITHIOL85VJA9KBCHIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
DIMETHICONE92RU3N3Y1OIACT
SUCROSEC151H8M554IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHERMVJ3AD73GGIACT
PANTHENOLWV9CM0O67ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM7FLD91C86KIACT

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
Essential Moisturizing SunscreenZINC OXIDE, OCTINOXATETopiderm, Inc.450d916e-4c77-489e-86b1-78b6863554762023-02-09WarningsExact identifier
ndc (package): 51326-122-20
ndc (product): 51326-122
ndc11 (package): 51326012220
spl id: 5fc4712e-bf0a-49e6-84e7-049b81f7b440
spl set id: 450d916e-4c77-489e-86b1-78b686355476

Reported adverse events (FAERS/openFDA)#

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