CAREONE 7-IN-1 ANTI-AGING VITAMIN- avobenzone, octisalate and octocrylene cream 
American Sales Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

CareOne® anti-aging vitamin complex

Active ingredient

Avobenzone 3.0

Octisalate 5.0%

Octocrylene 8.0%

Purpose

Sunscreen

Uses

Warnings

For external use only.

Do not use on

When using this product

Stop use and ask a doctor

Keep Out of Reach of Children.

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

Directions

Other 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

Principal display panel - carton label

Carton Label

CAREONE 7-IN-1 ANTI-AGING VITAMIN 
avobenzone, octisalate and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-869
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
PANTHENOL (UNII: WV9CM0O67Z)  
DOCOSANOL (UNII: 9G1OE216XY)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PEG-100 STEARATE (UNII: YD01N1999R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
COPPER GLUCONATE (UNII: RV823G6G67)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
DIHYDROXYACETONE (UNII: O10DDW6JOO)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-869-241 in 1 CARTON
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/11/2012
Labeler - American Sales Company (809183973)

Revised: 5/2012
Document Id: 61a4691e-e9ae-4d8b-91c2-f6cebef0f30a
Set id: 48e970cf-3776-41fd-962a-e8802d12d73d
Version: 2
Effective Time: 20120511
 
American Sales Company