FDA.reportPublic FDA data

CareOne Daily Moisturizer Broad Spectrum SPF15 Sunscreen

Manufacturer
American Sales Company
Effective date
2013-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:27

Label at a glance#

ProductCareOne Daily Moisturizer Broad Spectrum SPF15 Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE
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

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months of age: 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 3.0%

Octisalate 5.0%

Octocrylene 2.6%

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 on

  • damaged or broken skin.

 

When using this product

  • keep out of eyes. Rinse with water to remove.

 

Stop use 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 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months of age: 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 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses

Other Information

SPL UNCLASSIFIED SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, polyethylene, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 60, dimethicone, cetyl alcohol, cetearyl alcohol, cetearyl glucoside, panthenol (pro-vitamin B5), niacinamide, phenoxyethanol, methylparaben, ethylparaben, propylparaben, stearyl alcohol, cyclopentasiloxane, dimethiconol, behenyl alcohol, tocopheryl acetate (vitamin E), DMDM hydantoin, benzyl alcohol, PEG-4 dilaurate, stearic acid, PEG-100 stearate, fragrance, disodium EDTA

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CareOne® Daily Moisturizer

broad spectrum SPF15 sunscreen

With Vitamin E & Pro-Vitamin B5

*Compare to Olay® Complete
All Day UV Moisturizer SPF 15
Ingredients

  • Dermatologically tested
  • Non-Comedogenic (won't clog pores)
  • 100% Oil-Free
  • 100% PABA-Free

 

4 FL OZ (118 mL)

*This product is not made or distributed by Procter & Gamble, owner of the registered trademark Olay® Complete.

CareOne® Daily Moisturizer Broad Spectrum SPF15 Sunscreen provides broad spectrum protection, moisture and vitamins, for beautiful, healthy-looking skin.

  • Contains Pro-Vitamin B5 for moisturization and long-lasting hydration.
  • Antioxidant vitamins C & E promote and maintain healthy-looking skin.
  • Lightweight and non-greasy.

Directions for Use:
Every day, apply liberally on face and neck, as often as necessary.

DISTRIBUTED BY FOODHOLD, U.S.A., LLC
LANDOVER, MD 20785
1-877-846-9949
© 2013 S&S Brands, LLC

MADE IN ISRAEL

Quality guaranteed or your money back.
1D626 D4 C1

Carton Label
Carton Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-626-112020-01-31C16284748780-19d75b9d0-57eb-f424-e053-dadaa90a57ceCareOne Daily Moisturizer Broad Spectrum SPF15 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-626-11CareOne Daily Moisturizer Broad Spectrum SPF15 Sunscreen1 in 1 CARTONLOTION11
41520-626-11CareOne Daily Moisturizer Broad Spectrum SPF15 Sunscreen118 mL in 1 BOTTLELOTION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-626CAREONE DAILY MOISTURIZER BROAD SPECTRUM SPF15 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE) LOTION [AMERICAN SALES COMPANY]1Legacy NDC, 2 package rows20131115_17d07bd2-664f-4c67-8c00-0596a2d57ffa.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNA1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONOL (100000 CST)INACTIVE INGREDIENTOSA9UP217S1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW1
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
ETHYLPARABENINACTIVE INGREDIENT14255EXE391
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ41
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD41
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PEG-4 DILAURATEINACTIVE INGREDIENTKCR71CW0361
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
41520-62641520-626-11

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
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
ISOHEXADECANE918X1OUF1EIACT
POLYSORBATE 60CAL22UVI4MIACT
DIMETHICONE92RU3N3Y1OIACT
CETYL ALCOHOL936JST6JCNIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
PANTHENOLWV9CM0O67ZIACT
NIACINAMIDE25X51I8RD4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
PROPYLPARABENZ8IX2SC1OHIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONOL (100000 CST)OSA9UP217SIACT
DOCOSANOL9G1OE216XYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DMDM HYDANTOINBYR0546TOWIACT
BENZYL ALCOHOLLKG8494WBHIACT
PEG-4 DILAURATEKCR71CW036IACT
PEG-100 STEARATEYD01N1999RIACT
STEARIC ACID4ELV7Z65APIACT
EDETATE DISODIUM7FLD91C86KIACT

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 8 · 473 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYSTEM / TOPICAL42 mgExact identifier — unii candidate
79 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRAMUSCULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YOINTMENT / TOPICAL569 mgExact identifier — unii candidate
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION, CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / VAGINAL0.75 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
50 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, FILM COATED / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii candidate
9 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAVENOUS400 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR144 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / ORAL30 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRA-ARTICULAR0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRA-ARTICULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YSUPPOSITORY / VAGINAL8.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS18 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCONJUNCTIVAL252 mgExact identifier — unii candidate
50 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCONCENTRATE / ORAL12 mgExact identifier — unii candidate
79 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / VAGINAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / VAGINAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCAPSULE, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 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
17d07bd2-664f-4c67-8c00-0596a2d57ffa17d07bd2-664f-4c67-8c00-0596a2d57ffa2013-09-30WarningsExact identifier
spl id: 17d07bd2-664f-4c67-8c00-0596a2d57ffa
spl set id: 17d07bd2-664f-4c67-8c00-0596a2d57ffa

Reported adverse events (FAERS/openFDA)#

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