DAILY FACIAL MOISTURIZER SPF 35- octinoxate and avobenzone lotion

Daily Facial Moisturizer SPF 35 by

Drug Labeling and Warnings

Daily Facial Moisturizer SPF 35 by is a Otc medication manufactured, distributed, or labeled by Pharmco Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient:	Purpose
Avobenzone 2.5%	Sunscreen
Octinoxate 4%	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, Carthamus Tinctorius (Safflower) Oleosomes, C12-15 Alkyl Benzoate, C13-14 Isoparrafin, Laureth 7, Polyacrylamide, Benzyl Alcohol, Fragrance, Sodium Hydroxide, Methylisothiazolinone, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Citric Acid

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.-2 p.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 15-30°C (59-86°F). Protect the product in this container from excessive heat and or freezing conditions.

SPL UNCLASSIFIED SECTION

Manufactured by:
Pharmco Laboratories Inc. Titusville, FL 32780
www.pharmcolabs.com 1.800.635.0712 Reorder CPL16-3

PRINCIPAL DISPLAY PANEL - 87 g Tube Label

PHARMCO
SKINCARE LABS

Daily Facial
Moisturizer

Broad Spectrum SPF 30+

Net wt. 3 oz. (87 g)

INGREDIENTS AND APPEARANCE

DAILY FACIAL MOISTURIZER SPF 35 
octinoxate and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58400-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	40 mg  in 1 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Aloe (UNII: V5VD430YW9)
Benzyl Alcohol (UNII: LKG8494WBH)
Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Laureth-7 (UNII: Z95S6G8201)
Methylisothiazolinone (UNII: 229D0E1QFA)
Sodium Hydroxide (UNII: 55X04QC32I)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58400-007-01	87 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2012
2	NDC: 58400-007-02	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(58400-007) , LABEL(58400-007) , PACK(58400-007) , ANALYSIS(58400-007)