ANTI-AGING DAY PROTECT SPF 22- octinoxate, octisalate, and avobenzone lotion

Anti-Aging Day Protect SPF 22 by

Drug Labeling and Warnings

Anti-Aging Day Protect SPF 22 by is a Otc medication manufactured, distributed, or labeled by Swiss Botany, Pharmco Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
Avobenzone 2%	Sunscreen
Octinoxate 7.5%	Sunscreen
Octisalate 5%	Sunscreen

Uses

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection.
• Provides moderate protection for skin that sunburns easily

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 or irritation develops and lasts

• Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Directions

• After cleansing apply evenly to face and neck every morning, at least 15 minutes before sun exposure.
• Reapply as needed or after sweating or perspiring.
• Children under 6 months of age: Ask a doctor. (Not intended for use on children)

Other Ingredients

Acetyl Hexapeptide-3, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Camellia Sinensis (Green Tea) Extract, Capric/Caprylic Triglycerides, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Diaminopropionoyl Tripeptide-33, Dimethicone, Disodium EDTA, Fragrance, Glyceryl Stearate, Hexylene Glycol, Octyldodecanol, Squalane, PEG 100 Stearate, Phenoxyethanol, Polyacrylate-13, Polyisobutene, Polysorbate 20, Polysorbate 60, Propylene Glycol, Sodium Hydroxide, Stearyl Alcohol, Titanium Dioxide, Tocopheryl Acetate, Ubiquinone 50, Water.

Other Information

Moderate sun protection product.

SUN ALERT

Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 87 g Tube Label

SB

+Swiss Botany™

Anti-Aging
Day Protect SPF22

Net wt. 3 oz. (87 g)

INGREDIENTS AND APPEARANCE

ANTI-AGING DAY PROTECT SPF 22 
octinoxate, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70048-001
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 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)
Aloe (UNII: V5VD430YW9)
Benzyl Alcohol (UNII: LKG8494WBH)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Tricaprin (UNII: O1PB8EU98M)
Tricaprylin (UNII: 6P92858988)
Caprylyl Glycol (UNII: 00YIU5438U)
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)
Cetyl Alcohol (UNII: 936JST6JCN)
Dimethicone (UNII: 92RU3N3Y1O)
Edetate Sodium (UNII: MP1J8420LU)
Polyisobutylene (1000 MW) (UNII: 5XB3A63Y52)
Polysorbate 60 (UNII: CAL22UVI4M)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Hexylene Glycol (UNII: KEH0A3F75J)
Octyldodecanol (UNII: 461N1O614Y)
Squalane (UNII: GW89575KF9)
Peg-100 Stearate (UNII: YD01N1999R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 20 (UNII: 7T1F30V5YH)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Hydroxide (UNII: 55X04QC32I)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Titanium Dioxide (UNII: 15FIX9V2JP)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70048-001-01	87 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2012

Labeler - Swiss Botany (079860471)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmco Laboratories Inc.		096270814	MANUFACTURE(70048-001) , LABEL(70048-001) , PACK(70048-001) , ANALYSIS(70048-001)