SOLAR PROTECTION FORMULA SPF 58 SUNSCREEN- titanium dioxide, zinc oxide cream

Solar Protection Formula SPF 58 by

Drug Labeling and Warnings

Solar Protection Formula SPF 58 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:

Titanium Dioxide 10%

Zinc Oxide 3%

Purpose

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.

Directions:

• Apply liberally 15 minutes before sun exposure.
• Reapply:
  • After 40 minutes of swimming or sweating
  • Immediately after towel drying
  • 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.

Other Information:

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

Inactive Ingredients:

Acrylates C10-30 Alkyl Acrylates Crosspolymer, Butylene Glycol, Butyloctyl Salicylate, Butylparaben, Capric/Caprylic Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water, Xanthan Gum

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Carton Label

NDC: 58892-911-88

SOLAR
PROTECTION
FORMULA®

Gentle Mineral
Sunscreen

SPF 58
Broad Spectrum
Water Resistent
(40 minutes)

Net Wt. 2.5 Oz./ 70g

INGREDIENTS AND APPEARANCE

SOLAR PROTECTION FORMULA SPF 58   SUNSCREEN
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-911
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	100 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Butylene Glycol (UNII: 3XUS85K0RA)
Butylparaben (UNII: 3QPI1U3FV8)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cyclomethicone (UNII: NMQ347994Z)
Dimethicone (UNII: 92RU3N3Y1O)
Edetate Disodium (UNII: 7FLD91C86K)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Ferric Oxide Yellow (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
Isobutylparaben (UNII: 0QQJ25X58G)
Isopropylparaben (UNII: A6EOX47QK0)
Lemon Balm Oil (UNII: MJ76269K9S)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
Polyoxyl 100 Stearate (UNII: YD01N1999R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Sorbitan Monolaurate (UNII: 6W9PS8B71J)
Talc (UNII: 7SEV7J4R1U)
Alpha-Tocopherol (UNII: H4N855PNZ1)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-911-88	1 in 1 CARTON
1		70 g in 1 TUBE

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(58892-911)

Establishment
Name	Address	ID/FEI	Business Operations
Process Technologies & Packaging		809172885	MANUFACTURE(58892-911) , PACK(58892-911)