MOISTURIZER

Manufacturer
Oxygen Development LLC
Effective date
2023-02-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:52

Label at a glance#

ProductMOISTURIZER
Active ingredientHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure14 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours

Storage and handling

Protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octcrylene 1%

Oxygenzone 5%

Purpose: Sunscreen

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using

OTC - WHEN USING SECTION

this product keep out of eyes. Rinse with water to remove.

Stop Use

OTC - STOP USE SECTION

and ask a doctor if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • For sunscreen use:
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours

Sun Protection Measures

OTHER SAFETY INFORMATION

Spending time in the sun increased your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF valuye of 15 or higher and other sun protection measures inclusing:

  • limit time in the sun, specially from 10am - 2pm
  • children under 6 months of age: ask a doctor

other information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, butylene glycol, glyceryl stearate, cetearyl alcohol, glycerin, potassium cetyl phosphate, stearic acid, oligopeptide-24, polysorbate 60, polyester-8, sclerotium gum, bisabolol, phenoxyethanol, dimethicone, sodium PCA, squalana, tocopheryl acetate, helianthus annus (sunflower) seed oil, persea gratissima (avocado) oil, allantoin, caprylyl glycol, phytosterols, chlorphenesin, olea europaea (olive) fruit oil, disodium EDTA, glycolipids, sodium hyaluronate, citrus aurantium dulcis (orange) oil, zingiber officinale (ginger) root extract, tocopherol, citral, linalool, limonene

package label - primary

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-030-04_AW61354-030-04_AW

package label - secondary

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-030-08_AW61354-030-08_AW

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-035-04MOISTURIZER50 mg in 1 JARCREAM502
61354-035-08MOISTURIZER1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-035MOISTURIZER (AVOBENZONE, OXYBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE) CREAM [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bc034763-7e8a-503f-e053-2a95a90a9618.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-03561354-035-04, 61354-035-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
f45d48dd-ede5-06b9-e053-2995a90a1607bc034763-7e8a-503f-e053-2a95a90a96182023-02-10WarningsExact identifier
spl id: f45d48dd-ede5-06b9-e053-2995a90a1607
spl set id: bc034763-7e8a-503f-e053-2a95a90a9618

Reported adverse events (FAERS/openFDA)#

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