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

CareOne 7-in-1 Anti-Aging Vitamin by

Drug Labeling and Warnings

CareOne 7-in-1 Anti-Aging Vitamin by is a Otc medication manufactured, distributed, or labeled by American Sales Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 3.0

Octisalate 5.0%

Octocrylene 8.0%

Purpose

Sunscreen

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

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.

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

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 Information

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

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-869
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-869-24	1 in 1 CARTON
1		50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/11/2012

Labeler - American Sales Company (809183973)