Drug Facts

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.

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)

PRINCIPAL DISPLAY PANEL - 87 g Tube Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	06/01/2012

Labeler - Pharmco Laboratories Inc. (096270814)

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

Anti-Aging Day Protect SPF 22