FDA.reportPublic FDA data

Moisturizer

Manufacturer
Oxygen Development LLC
Effective date
2022-01-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:17

Label at a glance#

ProductMoisturizer
Active ingredientAVOBENZONE, OCTOCRYLENE, OXYBENZONE, OCTINOXATE
Label structure11 sections

Indications and uses

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

Dosage and administration

For sunscree use: apply liberally 15 minutes 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 increases your risk of skin cancer and early skin again. To decrease this risk, regulary use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: lomit time in the sun, esp...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Octinoxate 7.29%, Octocrylene 3.0%, Oxybenzone 2.0%

Uses

OTC - WHEN USING SECTION

Helps prevent sunburn

If used as directed with other sun protections 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

OTC - WHEN USING SECTION

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

Stop use

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscree use: apply liberally 15 minutes 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 increases your risk of skin cancer and early skin again. To decrease this risk, regulary use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: lomit time in the sun, especially from 10 a.m - 2 p.m. wear long - sleeve shirts, pants, hats, and sunglasses. Children unther 6 months: ask a doctor.

Other information

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-039-01_AW61354-039-01_AW

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-039-02_AW61354-039-02_AW

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-039-022025-01-30C16284748780-12cef2736-b1cc-d83d-e063-dadaa90ab31fLaura Mercier Pure Canvas Primer Protecting Broad Spectrum Spf 30 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-039-01Moisturizer100 g in 1 TUBECREAM1001
61354-039-02Moisturizer1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-039MOISTURIZER (AVOBENZONE) CREAM [OXYGEN DEVELOPMENT LLC]1Legacy NDC, 2 package rows20220104_d4b3eb40-c9d7-f356-e053-2a95a90a9a57.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-03961354-039-01, 61354-039-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
AVOBENZONEG63QQF2NOXACTIB
XANTHAN GUMTTV12P4NEEIACT
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
OXYBENZONE95OOS7VE0YACTIB
OCTINOXATE4Y5P7MUD51ACTIB
ISOHEXADECANE918X1OUF1EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT

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
d4b3eb40-c9d8-f356-e053-2a95a90a9a57d4b3eb40-c9d7-f356-e053-2a95a90a9a572022-01-03WarningsExact identifier
spl id: d4b3eb40-c9d8-f356-e053-2a95a90a9a57
spl set id: d4b3eb40-c9d7-f356-e053-2a95a90a9a57

Reported adverse events (FAERS/openFDA)#

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