FDA.reportPublic FDA data

Everyday Sunscreen SPF 50

Manufacturer
Taylor James | Cosway Company, Inc.
Effective date
2018-07-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:14

Label at a glance#

ProductEveryday Sunscreen SPF 50
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE, HOMOSALATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate 5% Sunscree

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

For External use only

Do not use on damaged or broken skin

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

If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply liberally 15 minutes before sun exposure

Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • 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 broad spectrum SPF 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: Ask a doctor

INACTIVE INGREDIENT SECTION

Water, Isododecane, Polyester-8, Glycerin, Cetyl Alcohol, Potassium Cetyl Phosphate, Acrylates Copolymer, Oryza Sativa (Rice) Bran Extract, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Sorbitan Olivate, Diethylhexyl Syringylidenemalonate, Aniba Rosaeodora (Rosewood) Wood Oil, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Ocimum Bascilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, 1,2-hexanediol, Caprylyl Glycol, Xanthan Gum, Helianthus Annuus (Sunflower) Extract, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Pentylene Glycol, Trisodium Ethylenediamene Disuccinate, Tocopheryl, Allantoin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride, Panthenol, Pentasodium Triphosphate, Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Everyday Sunscreen with Sunflower Extract

Broad Spectrum SPF 50

2.4 fl. oz./ 71 ml

tubetube

cartoncarton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75936-235-012021-01-29C16284748780-1ba0f9c33-238a-a910-e053-dadaa90a0b85Everyday Sunscreen SPF 50
75936-235-032021-01-29C16284748780-1ba0f9c33-238a-a910-e053-dadaa90a0b85Everyday Sunscreen SPF 50
75936-235-042021-01-29C16284748780-1ba0f9c33-238a-a910-e053-dadaa90a0b85Everyday Sunscreen SPF 50
75936-235-052021-01-29C16284748780-1ba0f9c33-238a-a910-e053-dadaa90a0b85Everyday Sunscreen SPF 50
75936-235-062021-01-29C16284748780-1ba0f9c33-238a-a910-e053-dadaa90a0b85Everyday Sunscreen SPF 50
75936-235-072021-01-29C16284748780-1ba0f9c33-238a-a910-e053-dadaa90a0b85Everyday Sunscreen SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75936-235-01Everyday Sunscreen SPF 5071 mL in 1 TUBECREAM711
75936-235-03Everyday Sunscreen SPF 5030 mL in 1 TUBECREAM301
75936-235-04Everyday Sunscreen SPF 50532 mL in 1 BOTTLECREAM5321
75936-235-05Everyday Sunscreen SPF 50222 mL in 1 BOTTLECREAM2221
75936-235-06Everyday Sunscreen SPF 503 mL in 1 PACKETCREAM31
75936-235-07Everyday Sunscreen SPF 5010 mL in 1 TUBECREAM101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75936-235EVERYDAY SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE) CREAM [TAYLOR JAMES]1Legacy NDC, 6 package rows20180711_705bf411-a4b1-d07f-e053-2991aa0ad1e1.zip

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75936-23575936-235-01, 75936-235-03, 75936-235-04, 75936-235-05, 75936-235-06, 75936-235-07

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ROSEMARYIJ67X351P9IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
BEHENIC ACIDH390488X0AIACT
CETYL BEHENATEWFM51TRO3EIACT
ISOSTEARYL ISOSTEARATEIV0Z586Z4YIACT
PENTYLENE GLYCOL50C1307PZGIACT
TOCOPHEROLR0ZB2556P8IACT
PANTHENOLWV9CM0O67ZIACT
ISODODECANEA8289P68Y2IACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
ROSEWOOD OILF2522O5L7BIACT
CHLORPHENESINI670DAL4SZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
OCIMUM BASILICUM FLOWERING TOP7SAB275FP2IACT
AVOBENZONEG63QQF2NOXACTIB
DIISOPROPYL SEBACATEJ8T3X564IHIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
CETEARYL OLIVATE58B69Q84JOIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
SORBITAN OLIVATEMDL271E3GRIACT
ORANGE OILAKN3KSD11BIACT
EUCALYPTUS OIL2R04ONI662IACT
PATCHOULI OILF3IN55X5POIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
XANTHAN GUMTTV12P4NEEIACT
ALLANTOIN344S277G0ZIACT
GLYCERINPDC6A3C0OXIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
RICE BRANR60QEP13ICIACT
LAURYL LACTATEG5SU0BFK7OIACT
LEMON OILI9GRO824LLIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
HOMOSALATEV06SV4M95SACTIB

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
705bf411-a4b2-d07f-e053-2991aa0ad1e1705bf411-a4b1-d07f-e053-2991aa0ad1e12018-07-06WarningsExact identifier
spl id: 705bf411-a4b2-d07f-e053-2991aa0ad1e1
spl set id: 705bf411-a4b1-d07f-e053-2991aa0ad1e1

Reported adverse events (FAERS/openFDA)#

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