Solar Protection Formula Tizo Body Sunscreen

Solar Protection Formula Tizo Body Sunscreen
SPL v1
SPL
SPL Set ID 28ce4b2f-f925-47a6-aa2e-e71cd4658e0d
Route
TOPICAL
Published
Effective Date 2010-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
C12-15 Alkyl Benzoate Caprylhydroxamic Acid Caprylyl Glycol Cyclomethicone 6 Cyclomethicone 5 Dimethicone Edetate Disodium Glycerin Hydroxystearic Acid Polysorbate 20 Sodium Chloride Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate, D- Trolamine Octyltriethoxysilane Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-08-01

Description

DRUG FACTS

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

DRUG FACTS

Uses
  • Helps prevent sunburn
  • Provides protection from UVA & UVB rays that may contribute to premature aging of the skin
  • Retains SPF up to 40 minutes of water immersion or perspiring
Section 42229-5

DRUG FACTS

Warnings
  • For external use only
  • Avoid contact with eyes. In case of eye contact, flush eyes with water thoroughly
  • Do not use if sensitive to ingredients
  • Discontinue use if irritation occurs. Consult a doctor or healthcare professional if irritation persists
  • For use on children less than 6 months of age, consult a doctor
  • Keep this and all medicines out of the reach of children
  • If swallowed, get medical help or contact a Poison Control Center
Directions
  • Apply generously and uniformly to all exposed skin areas before exposure to sunlight
  • Continue to rub in until fading occurs, especially in hair bearing areas
  • Reapply as needed and after washing, swimming, towel drying, or sweating for maximum protection
Other Information
  • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • May stain some fabrics
Spf Is Not Enough

UVA radiation is consistently the same all day and all year long. Everyone requires daily, year round UVA protection. UVA radiation is responsible for deep skin damage that results in most of the changes associated with skin aging, such as wrinkling. In addition, the effects of UVA damage are cumulative. Since the SPF number does not define the level of UVA protection, products that utilize both titanium dioxide and/or zinc oxide, are the best method of assuring full spectrum sun protection from UVA and UVB radiation.

  • Excellent for Sensitive Skin
  • Free of "Chemical Sunscreen Filters"
  • Contains no Parabens
  • Dries Translucent
  • Full Spectrum Protection
  • Fragrance Free

Manufactured exclusively for

Fallien, Ltd.

West Norriton PA 19403

Made in USA

Active Ingredients:

Zinc Oxide 20%

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxyamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylysilane, Water

TiZO Body SPF 35 is a sunscreen uniquely formulated to offer sheer, elegant protection with a silky, smooth, matte finish. TiZO Body offers unparalleled aesthetic elegance while providing superb photoprotective performance. Using our proprietary technology, Fallien has formulated multiple particle sizes of micronized zinc oxide into a light, silky texture that dries to a clear, yet matte finish on any complexion. TiZO Body is paraben, oil and fragrance free, and specially formulated without UV absorbing chemicals to offer unsurpassed, irritant free UVA/UVB light protection.

Principal Display Panel – Carton Label

NDC 58892-218-01

SOLAR

PROTECTION

Formula®

TIZO ®

BODY

20% Zinc Oxide Mineral Protection

Water Resistant

spf 35

uva/uvb

Net Wt 3.5 oz. / 100g


Structured Label Content

Uses
  • Helps prevent sunburn
  • Provides protection from UVA & UVB rays that may contribute to premature aging of the skin
  • Retains SPF up to 40 minutes of water immersion or perspiring
Section 42229-5 (42229-5)

DRUG FACTS

Purpose

Sunscreen

Warnings
  • For external use only
  • Avoid contact with eyes. In case of eye contact, flush eyes with water thoroughly
  • Do not use if sensitive to ingredients
  • Discontinue use if irritation occurs. Consult a doctor or healthcare professional if irritation persists
  • For use on children less than 6 months of age, consult a doctor
  • Keep this and all medicines out of the reach of children
  • If swallowed, get medical help or contact a Poison Control Center
Directions
  • Apply generously and uniformly to all exposed skin areas before exposure to sunlight
  • Continue to rub in until fading occurs, especially in hair bearing areas
  • Reapply as needed and after washing, swimming, towel drying, or sweating for maximum protection
Other Information
  • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • May stain some fabrics
Spf Is Not Enough (SPF is not Enough)

UVA radiation is consistently the same all day and all year long. Everyone requires daily, year round UVA protection. UVA radiation is responsible for deep skin damage that results in most of the changes associated with skin aging, such as wrinkling. In addition, the effects of UVA damage are cumulative. Since the SPF number does not define the level of UVA protection, products that utilize both titanium dioxide and/or zinc oxide, are the best method of assuring full spectrum sun protection from UVA and UVB radiation.

  • Excellent for Sensitive Skin
  • Free of "Chemical Sunscreen Filters"
  • Contains no Parabens
  • Dries Translucent
  • Full Spectrum Protection
  • Fragrance Free

Manufactured exclusively for

Fallien, Ltd.

West Norriton PA 19403

Made in USA

Active Ingredients:

Zinc Oxide 20%

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxyamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylysilane, Water

TiZO Body SPF 35 is a sunscreen uniquely formulated to offer sheer, elegant protection with a silky, smooth, matte finish. TiZO Body offers unparalleled aesthetic elegance while providing superb photoprotective performance. Using our proprietary technology, Fallien has formulated multiple particle sizes of micronized zinc oxide into a light, silky texture that dries to a clear, yet matte finish on any complexion. TiZO Body is paraben, oil and fragrance free, and specially formulated without UV absorbing chemicals to offer unsurpassed, irritant free UVA/UVB light protection.

Principal Display Panel – Carton Label

NDC 58892-218-01

SOLAR

PROTECTION

Formula®

TIZO ®

BODY

20% Zinc Oxide Mineral Protection

Water Resistant

spf 35

uva/uvb

Net Wt 3.5 oz. / 100g


Advanced Ingredient Data


Raw Label Data

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