FDA.reportPublic FDA data

Antioxidant Day SPF 15

Manufacturer
Columbia Cosmetics Manufacturing, Inc.
Effective date
2021-10-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:30:25

Label at a glance#

ProductAntioxidant Day SPF 15
Active ingredientOCTISALATE, OCTINOXATE, OXYBENZONE
Label structure9 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply liberally 15 minutes 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.  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 inclu...

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Sunscreen

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE (7.5%)
OCTISALATE (3.0%)
OXYBENZONE (3.0%)

Uses:

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings:

WARNINGS SECTION

For external use only

Skin cancer / Skin Aging Alert: Spending time in the sun increases yourrisk of skin cancer and early skin aging. This product has been shown to prevent sunburn, not skin cancer or early skin aging

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

When using this product

OTC - WHEN USING SECTION

keep out of eyes.  Rinse with water to remove.

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 minutes 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.  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 AM to 2 PM
  • wear long-sleeved shirts, pants, hats and sunglasses.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

WATER (AQUA), GLYCERYL STEARATE, CYCLOPENTASILOXANE, SQUALANE, BUTYLENE GLYCOL, GLYCERIN, PROPYLENE GLYCOL, ALOE BARBADENSIS LEAF EXTRACT, SORBITAN STEARATE, C12-20 ACID PEG-8 ESTER, CYCLOHEXASILOXANE, CETEARETH-20, POTASSIUM CETYL PHOSPHATE, PINUS HAEDA BARK EXTRACT, PHENOXYETHANOL, CAPRYLYL GLYCOL, CARBOMER, MAGNESIUM ALUMINUM SILICATE, ETHYLHEXYLGLYCERIN, ALLANTOIN,HEXYLENE GLYCOL, PANTHENOL, RETINYL PALMITATE, TOCOPHERYL ACETATE, SODIUM HYDROXIDE, PEG-8,TOCOPHEROL, ASCORBYL PALMITATE, ASCORBIC ACID,CITRIC ACID, TITANIUM DIOXIDE CI 77891.

Other information:

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antioxidant Day Creme SPF15    Paraben-free  Sulfate-free    2.0 FL OZ  59mL   MADE IN USA   A moisturizing day creme formulated with Pine Bark Extract, Aloe and Vitamins A, B5, C and E

Antioxidant Day Creme SPF 15 2oz/59ml (61016-0002-2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61016-0002-22023-01-30C16284748780-1f386c649-9cce-0266-e053-dadaa90a7c1aAntioxidant Day Creme SPF 15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTISALATEACTIVE MOIETY4X49Y0596W2
OXYBENZONEACTIVE MOIETY95OOS7VE0Y2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ALLANTOININACTIVE INGREDIENT344S277G0Z2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R2
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BA2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ2
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUY2
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UT2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X2
SQUALANEINACTIVE INGREDIENTGW89575KF92
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P82
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61016-000261016-0002-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALLANTOIN344S277G0ZIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
PANTHENOLWV9CM0O67ZIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM HYDROXIDE55X04QC32IIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TOCOPHEROLR0ZB2556P8IACT
ASCORBYL PALMITATEQN83US2B0NIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CYCLOMETHICONE 50THT5PCI0RIACT
SQUALANEGW89575KF9IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
CYCLOMETHICONE 6XHK3U310BAIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 11 · 610 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XTABLET / ORAL4 mgExact identifier — unii candidate
11 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSYRUP / ORAL100 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / NASAL2.8 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBCONJUNCTIVALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL, METERED / TRANSDERMAL350 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / SUBLINGUAL1.23 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IJELLY / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINHALANT / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SUSPENSION / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET / ORAL10 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS136.55 mgExact identifier — unii candidate
174 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / RECTAL0.25 mg/mgExact identifier — unii candidate
36 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INTRAVENOUS4 mgExact identifier — unii candidate
25 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCREAM / TOPICAL10 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / IRRIGATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii candidate
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / OPHTHALMIC1.5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-AMNIOTICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
25 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCAPSULE / ORAL7 mgExact identifier — unii candidate
25 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates

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
cf47b4fc-c0d2-65f4-e053-2995a90a8885618dbcca-4d52-4775-b21c-1a42a45130ca2021-10-26WarningsExact identifier
spl id: cf47b4fc-c0d2-65f4-e053-2995a90a8885
spl set id: 618dbcca-4d52-4775-b21c-1a42a45130ca

Reported adverse events (FAERS/openFDA)#

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