SOLAR PROTECTION FORMULA SPF 65 SUNSCREEN- octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion

Solar Protection Formula SPF 65 by

Drug Labeling and Warnings

Solar Protection Formula SPF 65 by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, LTD., Custom Analytics LLC, Process Technologies & Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients:

Octinoxate 6%

Octocrylene 7%

Oxybenzone 4%

Titanium Dioxide 4%

Zinc Oxide 5%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses:

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

For external use only.

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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

SHAKE WELL BEFORE USING

Other Information:

• Protect this product from excessive heat and direct sun
• May stain some fabrics

Directions:

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant product 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 10:00 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Acrylates/Octylacrylamide Copolymer, Aluminum Starch Octenylsuccinate, Ascorbyl Palmitate, 5-Bromo-5-Nitro-1, 3-Dioxane, Beta-Carotene, Butylparaben, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside, Dimethicone, Disodium EDTA, Iron Oxides, Isobutylparaben, Isopropylparaben, Linoleamidopropyl Dimethylamine, Octyldodecyl Neopentanoate, Phenoxyethanol, Pinus Pinaster Bark Extract, Polysorbate 20, Propylene Glycol, Selenium Yeast Extract, Simethicone, Sorbitan Laurate, Talc, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

Solar Protection Formula combines Titanium Dioxide, Zinc Oxide, and Iron Oxide to form a complete wall of reflection against UVA/UVB damage.

Manufactured exclusively for
Fallien Ltd., West Norriton, PA
Made in USA

Principal Display Panel – 2 oz Carton Label

NDC: 58892-265-59

SOLAR

PROTECTION

FORMULA®

Oil Free

Non-comedogenic

SPF 65

Broad Spectrum

UVA/UVB

2 Fl. Oz. / 58.8ml

INGREDIENTS AND APPEARANCE

SOLAR PROTECTION FORMULA SPF 65   SUNSCREEN
octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-265
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	60 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	70 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	40 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	40 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Ascorbyl Palmitate (UNII: QN83US2B0N)
5-Bromo-5-Nitro-1,3-Dioxane (UNII: U184I9QBNM)
.Beta.-Carotene (UNII: 01YAE03M7J)
Butylparaben (UNII: 3QPI1U3FV8)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Dimethicone (UNII: 92RU3N3Y1O)
Edetate Disodium (UNII: 7FLD91C86K)
Ferric Oxide Red (UNII: 1K09F3G675)
Isobutylparaben (UNII: 0QQJ25X58G)
Isopropylparaben (UNII: A6EOX47QK0)
Linoleamidopropyl Dimethylamine (UNII: W142CF4WLF)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Phenoxyethanol (UNII: HIE492ZZ3T)
Maritime Pine (UNII: 50JZ5Z98QY)
Polysorbate 20 (UNII: 7T1F30V5YH)
Propylene Glycol (UNII: 6DC9Q167V3)
Sorbitan Monolaurate (UNII: 6W9PS8B71J)
Talc (UNII: 7SEV7J4R1U)
Tocopherol (UNII: R0ZB2556P8)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-265-59	1 in 1 CARTON
1		58.8 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2004

Labeler - Fallien Cosmeceuticals, LTD. (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	ANALYSIS(58892-265)

Establishment
Name	Address	ID/FEI	Business Operations
Process Technologies & Packaging		809172885	MANUFACTURE(58892-265)