cream

Manufacturer
Oxygen Development LLC
Effective date
2023-02-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:53:51

Label at a glance#

Productcream
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure14 sections

Indications and uses

helps prevent sunburn If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by sun

Dosage and administration

Apply liberally 15 mins before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: ask a doctor

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 5%, Zinc Oxide 5%. Purpose: sunscreen

purpose

OTC - PURPOSE SECTION

sunscreen

uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by 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

  • Apply liberally 15 mins before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor

sun protection measures

OTHER SAFETY INFORMATION

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 at least 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10am - 2pm
  • wear long-sleeved shirts, pants, hats, and sunglasses

inactive ingredients

INACTIVE INGREDIENT SECTION

water (aqua/eau), Acetamidoethoxyethanol, Tridecyl Trimellitate, Octyldodecyl Neopentanoate, polysilicone-31, niacinimide, Cyclopentasiloxane, Cetyl Alcohol, C12-15 Alkyl Benzoate, Butylene Glycol, Aluminum Starch Octenylsuccinate, Caprylyl Methicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Isohexadecane, mica, Potassium Cetyl Phosphate, Peg-8 Dimethicone, PEG-100 Stearate, Glyceryl Stearate, glycerin, yeast extract, xanthan gum, Polyhydroxystearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Triethoxycaprylylsilane, polysorbate 80, soy amino acids, Ethylhexylglycerin, Tetrahexyldecyl Ascorbate, Arnica Montana Flower Extract.

other information

STORAGE AND HANDLING SECTION

protect this product from excessive heat and direct sun

package label - primary

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-070-03_AW primary61354-070-03_AW primary

package label - secondary

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-070-07_AW secondary61354-070-07_AW secondary

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-070-04cream40 mg in 1 TUBECREAM403
61354-070-08cream1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-070CREAM (OCTINOXATE, ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]3Legacy NDC, 2 package rows20230211_bbf4e4ca-8b3b-4298-e053-2995a90ad847.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-07061354-070-04, 61354-070-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
f45d6b8d-6548-5e3d-e053-2a95a90a7b6bbbf4e4ca-8b3b-4298-e053-2995a90ad8472023-02-10WarningsExact identifier
spl id: f45d6b8d-6548-5e3d-e053-2a95a90a7b6b
spl set id: bbf4e4ca-8b3b-4298-e053-2995a90ad847

Reported adverse events (FAERS/openFDA)#

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