FDA.reportPublic FDA data

SENSITF OIL FREE LOTION REVIVE BROAD SPECTRUM SPF 15 SUNSCREEN

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 23:53:56

Label at a glance#

ProductMOISTURIZER
Active ingredientOCTINOXATE, AVOBENZONE
Label structure9 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

For suncreen 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. 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 value of 15 or higher and other sun protection measures including: Limit time in ...

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 3.0%, Octinoxate 7.5%.

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 aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Do Not Use

OTC - DO NOT USE SECTION

Do Not Use on damaged 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

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 swallowed, get medical help or contact a Posion Contorl Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For suncreen 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. 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 value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses
  • 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, diisopropyl sebacate, butylene gycol, cyclopentasiloxane, glyceryl stearate, stearic acid, cetyl phosphate, cetearyl alcohol, sh-oligopeptide-1, phenoxyethanol, sodium PCA, polysorbate 60, aminomethyl propanol, citrus aurantium dulcis (orange) fruit extract, allantoin, methylparaben, carbomer, bisabolol, propylparaben, tocopheryl acetate, disodium EDTA, laminaria saccharina extract, glycolipids, sodium hyaluronate.

Primary package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-032-01_AW61354-032-01_AW60 ml 61354-032-01

Secondary package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-032-01_AW61354-032-01_AW61354-032-01_AW61354-032-01_AW60ml, 61354-032-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-032-012025-01-30C16284748780-1f386c649-ff36-0266-e053-dadaa90a7c1aSENSITF OIL FREE LOTION REVIVE BROAD SPECTRUM SPF 15 SUNSCREEN
61354-032-012023-02-10C16284748780-1f386c649-ff36-0266-e053-dadaa90a7c1aSENSITF OIL FREE LOTION REVIVE BROAD SPECTRUM SPF 15 SUNSCREEN
61354-032-012023-01-30C16284748780-1f386c649-ff36-0266-e053-dadaa90a7c1aSENSITF OIL FREE LOTION REVIVE BROAD SPECTRUM SPF 15 SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-032-01MOISTURIZER60 mg in 1 BOTTLECREAM602
61354-032-01MOISTURIZER1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-032MOISTURIZER (AVOBENZONE, OCTINOXATE) CREAM [OXYGEN DEVELOPMENT, LLC]2Legacy NDC, 2 package rows20230211_bc3db9a4-2577-6d04-e053-2a95a90a0008.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-03261354-032-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIISOPROPYL SEBACATEJ8T3X564IHIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
STEARIC ACID4ELV7Z65APIACT
CETYL PHOSPHATEVT07D6X67OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT

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
f45d0098-02ce-f8d6-e053-2a95a90ae8aabc3db9a4-2577-6d04-e053-2a95a90a00082023-02-10WarningsExact identifier
spl id: f45d0098-02ce-f8d6-e053-2a95a90ae8aa
spl set id: bc3db9a4-2577-6d04-e053-2a95a90a0008

Reported adverse events (FAERS/openFDA)#

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