ANTIOXIDANT DAY SPF 15- octinoxate, octisalate, oxybenzone cream

Antioxidant Day SPF 15 by

Drug Labeling and Warnings

Antioxidant Day SPF 15 by is a Otc medication manufactured, distributed, or labeled by Columbia Cosmetics Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Purpose

Sunscreen

Active ingredients:

OCTINOXATE (7.5%)
OCTISALATE (3.0%)
OXYBENZONE (3.0%)

Uses:

• helps prevent sunburn

Warnings:

For external use only

Skin cancer / Skin Aging Alert: Spending time in the sun increases yourrisk of skin cancer and early skin aging. This product has been shown to prevent sunburn, not skin cancer or early skin aging

Do not use

on damaged or broken skin.

Stop use and ask a doctor

if rash occurs.

When using this product

keep out of eyes.  Rinse with water to remove.

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
• use a water-resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: 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 AM to 2 PM
• wear long-sleeved shirts, pants, hats and sunglasses.
  

Inactive ingredients:

WATER (AQUA), GLYCERYL STEARATE, CYCLOPENTASILOXANE, SQUALANE, BUTYLENE GLYCOL, GLYCERIN, PROPYLENE GLYCOL, ALOE BARBADENSIS LEAF EXTRACT, SORBITAN STEARATE, C12-20 ACID PEG-8 ESTER, CYCLOHEXASILOXANE, CETEARETH-20, POTASSIUM CETYL PHOSPHATE, PINUS HAEDA BARK EXTRACT, PHENOXYETHANOL, CAPRYLYL GLYCOL, CARBOMER, MAGNESIUM ALUMINUM SILICATE, ETHYLHEXYLGLYCERIN, ALLANTOIN,HEXYLENE GLYCOL, PANTHENOL, RETINYL PALMITATE, TOCOPHERYL ACETATE, SODIUM HYDROXIDE, PEG-8,TOCOPHEROL, ASCORBYL PALMITATE, ASCORBIC ACID,CITRIC ACID, TITANIUM DIOXIDE CI 77891.

Other information:

• protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

Antioxidant Day Creme SPF15    Paraben-free  Sulfate-free    2.0 FL OZ  59mL   MADE IN USA   A moisturizing day creme formulated with Pine Bark Extract, Aloe and Vitamins A, B5, C and E

Antioxidant Day Creme SPF 15 2oz/59ml (

61016-0002-2)

INGREDIENTS AND APPEARANCE

ANTIOXIDANT DAY SPF 15 
octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61016-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SQUALANE (UNII: GW89575KF9)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALLANTOIN (UNII: 344S277G0Z)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PANTHENOL (UNII: WV9CM0O67Z)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61016-0002-2	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/19/2012

Labeler - Columbia Cosmetics Manufacturing, Inc. (068267863)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	manufacture(61016-0002)