FDA.reportPublic FDA data

CareOne 7-in-1 Anti-Aging Vitamin

Manufacturer
American Sales Company
Effective date
2012-05-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:31:59

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Avobenzone 3.0 Octisalate 5.0% Octocrylene 8.0%

Purpose

Sunscreen

Uses

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

Warnings

Warnings

For external use only.

Do not use on

damaged or broken skin.

Stop use and ask a doctor

if rash occurs.

Directions And Dosage

Directions

Apply liberally 15 minutes before sun exposure. 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 Label Information

Inactive Ingredients

water, glycerin, isopropyl isostearate, boron nitride, sodium carboxymethyl beta-glucan, polyacrylamide, C13-14 isoparaffin, laureth-7, cetyl alcohol, stearyl alcohol, cyclopentasiloxane, dimethiconol, dimethicone, cetearyl alcohol, cetearyl glucoside, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, sorbitan stearate, panthenol (pro-vitamin B5), behenyl alcohol, tocopheryl acetate (vitamin E), benzyl alcohol, disodium EDTA, PEG-100 stearate, stearic acid, ascorbyl tetraisopalmitate, magnesium aspartate, zinc gluconate, copper gluconate, calcium gluconate, dihydroxyacetone

Package/Label Principal Display Panel

CareOne ® anti-aging vitamin complex 7-in-1 broad spectrum SPF15 sunscreen fragrance free 7 anti-aging treatments in 1 vitamin and antioxidant moisturizer + broad spectrum SPF15 protection for younger-looking skin 1.7 FL OZ (50 mL) DISTRIBUTED BY: AMERICAN SALES COMPANY 4201 WALDEN AVENUE LANCASTER, NY 14086 www.care1.info © 2012 S&S Brands, Inc. Quality guaranteed or your money back. Manufactured in Israel 2F692 D4 C2 Carton Label

Label Images#

61a4691e-e9ae-4d8b-91c2-f6cebef0f30a-01
61a4691e-e9ae-4d8b-91c2-f6cebef0f30a-01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-869-242020-01-31C16284748780-19d75b9d1-1b1b-f424-e053-dadaa90a57ceCareOne ® anti-aging vitamin complex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-869-24CareOne 7-in-1 Anti-Aging Vitamin50 mL in 1 BOTTLECREAM502
41520-869-24CareOne 7-in-1 Anti-Aging Vitamin1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-869CAREONE 7-IN-1 ANTI-AGING VITAMIN (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) CREAM [AMERICAN SALES COMPANY]2Legacy NDC, 2 package rows20120522_48e970cf-3776-41fd-962a-e8802d12d73d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
OCTISALATEACTIVE MOIETY4X49Y0596W2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH2
BORON NITRIDEINACTIVE INGREDIENT2U4T60A6YD2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV82
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE702
CALCIUM GLUCONATEINACTIVE INGREDIENTSQE6VB453K2
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNA2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
COPPER GLUCONATEINACTIVE INGREDIENTRV823G6G672
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
DIHYDROXYACETONEINACTIVE INGREDIENTO10DDW6JOO2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
DIMETHICONOL (250000 MW)INACTIVE INGREDIENTRKI3S914RT2
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
ETHYLPARABENINACTIVE INGREDIENT14255EXE392
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58G2
ISOPROPYL ISOSTEARATEINACTIVE INGREDIENTC67IXB9Y7T2
LAURETH-7INACTIVE INGREDIENTZ95S6G82012
MAGNESIUM ASPARTATEINACTIVE INGREDIENTR17X820ROL2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYACRYLAMIDE (10000 MW)INACTIVE INGREDIENTE2KR9C9V2I2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A22
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y2
WATERINACTIVE INGREDIENT059QF0KO0R2
ZINC GLUCONATEINACTIVE INGREDIENTU6WSN5SQ1Z2

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-86941520-869-24

Ingredients#

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ISOSTEARATEC67IXB9Y7TIACT
BORON NITRIDE2U4T60A6YDIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
CETYL ALCOHOL936JST6JCNIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONOL (250000 MW)RKI3S914RTIACT
DIMETHICONE92RU3N3Y1OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
BUTYLPARABEN3QPI1U3FV8IACT
PROPYLPARABENZ8IX2SC1OHIACT
ISOBUTYLPARABEN0QQJ25X58GIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
PANTHENOLWV9CM0O67ZIACT
DOCOSANOL9G1OE216XYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE DISODIUM7FLD91C86KIACT
PEG-100 STEARATEYD01N1999RIACT
STEARIC ACID4ELV7Z65APIACT
ASCORBYL PALMITATEQN83US2B0NIACT
MAGNESIUM ASPARTATER17X820ROLIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
COPPER GLUCONATERV823G6G67IACT
CALCIUM GLUCONATESQE6VB453KIACT
DIHYDROXYACETONEO10DDW6JOOIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT

Complete SPL Sections#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0 Octisalate 5.0% Octocrylene 8.0%

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

OTC - DO NOT USE SECTION

damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

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. 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, isopropyl isostearate, boron nitride, sodium carboxymethyl beta-glucan, polyacrylamide, C13-14 isoparaffin, laureth-7, cetyl alcohol, stearyl alcohol, cyclopentasiloxane, dimethiconol, dimethicone, cetearyl alcohol, cetearyl glucoside, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, sorbitan stearate, panthenol (pro-vitamin B5), behenyl alcohol, tocopheryl acetate (vitamin E), benzyl alcohol, disodium EDTA, PEG-100 stearate, stearic acid, ascorbyl tetraisopalmitate, magnesium aspartate, zinc gluconate, copper gluconate, calcium gluconate, dihydroxyacetone

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CareOne ® anti-aging vitamin complex 7-in-1 broad spectrum SPF15 sunscreen fragrance free 7 anti-aging treatments in 1 vitamin and antioxidant moisturizer + broad spectrum SPF15 protection for younger-looking skin 1.7 FL OZ (50 mL) DISTRIBUTED BY: AMERICAN SALES COMPANY 4201 WALDEN AVENUE LANCASTER, NY 14086 www.care1.info © 2012 S&S Brands, Inc. Quality guaranteed or your money back. Manufactured in Israel 2F692 D4 C2 Carton Label

Source Document#

Source XML