FDA.reportPublic FDA data

Moisturizer

Manufacturer
Oxygen Development LLC
Effective date
2022-01-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:21

Label at a glance#

ProductMoisturizer
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE, OXYBENZONE, OCTISALATE
Label structure13 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 again 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. Sun protections measures. Spending time in the sun increasses your risk of skin cancer and early skin aging. To decrease this risk, regulary use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time ...

Label contents#

Full prescribing information#

Ative ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%. Hosmosalate 10.0%. Octisalate 5.0%. Octocrylene 1.0%. Oxybenzone 5.0%

Purpose

OTC - PURPOSE SECTION

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 again caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use on damage or broken skin

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use 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 rigth 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 protections measures. Spending time in the sun increasses your risk of skin cancer and early skin aging. To decrease this risk, regulary use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun. especially from 10 a.m - 2 p.m. Wear long - sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.

Other information

OTHER SAFETY INFORMATION

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, Squalane, Tocopheryl Acetate, Helianthus Annuus (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 principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-041-01_AW61354-041-01_AW

Package label principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-041-02_AW61354-041-02_AW

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-041-022025-01-30C16284748780-12cef2736-6d6d-d83d-e063-dadaa90ab31fRevive Sensitif Renewal Daily Cellular Protection Broad Spectrum Spf 30 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-041-01Moisturizer100 g in 1 JARCREAM1001
61354-041-02Moisturizer1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-041MOISTURIZER (AVOBENZONE) CREAM [OXYGEN DEVELOPMENT LLC]1Legacy NDC, 2 package rows20220105_d4c411de-efaa-7866-e053-2995a90aadb0.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-04161354-041-01, 61354-041-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SQUALANEGW89575KF9IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
GLYCERINPDC6A3C0OXIACT
HOMOSALATEV06SV4M95SACTIB
LEVOMENOL24WE03BX2TIACT
WATER059QF0KO0RIACT
OXYBENZONE95OOS7VE0YACTIB
OCTISALATE4X49Y0596WACTIB
STEARIC ACID4ELV7Z65APIACT
BETASIZOFIRAN2X51AD1X3TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE92RU3N3Y1OIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
POLYSORBATE 60CAL22UVI4MIACT

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
d4c411de-efab-7866-e053-2995a90aadb0d4c411de-efaa-7866-e053-2995a90aadb02022-01-04WarningsExact identifier
spl id: d4c411de-efab-7866-e053-2995a90aadb0
spl set id: d4c411de-efaa-7866-e053-2995a90aadb0

Reported adverse events (FAERS/openFDA)#

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