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 Pharmco Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

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

Uses

• Helps prevent sunburn.

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.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours or after sweating.
• Children under 6 months of age: Ask a doctor. (Not intended for use on children)

Other Ingredients

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

Skin Cancer/Skin Aging Alert & 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.-2p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses

This product has been shown to help prevent sun burn, not skin cancer or early skin aging.

Other Information

Store at 15 - 25°C (59 - 77°F). Protect the product in this container from excessive heat and freezing conditions.

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.

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Manufactured by:
Pharmco Laboratories Inc. Titusville, FL 32780

PRINCIPAL DISPLAY PANEL - 87 g Tube Label

PHARMCO
SKINCARE LABS

Anti-Aging
Day Protect
SPF 22

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: 58400-006
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 350 (UNII: 2Y53S6ATLU)
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: 58400-006-01	87 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2012
2	NDC: 58400-006-02	3900 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2012

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

Labeler - Pharmco Laboratories Inc. (096270814)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmco Laboratories Inc.		096270814	MANUFACTURE(58400-006) , LABEL(58400-006) , PACK(58400-006) , ANALYSIS(58400-006)