Perbelle Cc Cream Spf43 Uva/uvb Broad Spectrum

Perbelle Cc Cream Spf43 Uva/uvb Broad Spectrum
SPL v3
SPL
SPL Set ID b5e2724e-9806-5bcc-e053-2a95a90a0508
Route
TOPICAL
Published
Effective Date 2020-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (120 mg)
Inactive Ingredients
Ferric Oxide Yellow Ferrosoferric Oxide Propylparaben Methylparaben Phenoxyethanol Water Octinoxate Cyclomethicone Cyclomethicone 5 Hexyl Laurate Butylene Glycol Isodecyl Neopentanoate Amorphophallus Konjac Root Methyl Trimethicone Bemotrizinol Poly(methyl Methacrylate; 450000 Mw) Alkyl (c12-15) Benzoate Niacinamide Peg-10 Dimethicone (600 Cst) Talc Silicon Dioxide Sodium Chloride Nelumbo Nucifera Flower Jasminum Officinale Flower Lilium Candidum Bulb Iris Versicolor Root Leontopodium Nivale Subsp. Alpinum Flowering Top Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Sorbitan Olivate Hyaluronic Acid Sorbitan Isostearate Dimethicone Calcium Stearate Lauryl Peg/ppg-18/18 Methicone Glycerin Triethoxycaprylylsilane Sorbitan Sesquioleate Trihydroxystearin Trolamine Adenosine Aluminum Hydroxide Stearic Acid Magnesium Potassium Aluminosilicate Fluoride Silica Dimethyl Silylate Zein Starch, Corn Medium-chain Triglycerides Edetate Disodium Anhydrous Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-20

Description

TITANIUM DIOXIDE 12%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

TITANIUM DIOXIDE 12%

Uses
  • Helps protect sunburns 
  • 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

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water reistant sunscreen if swimming or sweating.
  • spending time in the sun increases your risk of skin cancer and early skin aging. To decrese this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other skin protection measures including: Sun Protection Measures
  • Limit time in the sun, especially from 10 am - 2 pm.
  • Wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months of age Ask  doctor.
Do Not Use

on damaged or broken skin

Drug Facts

Questions?

Call 646.328.6562

Other Information
  • Protect the product in this container from excessive heat or direct sun.
Package Labeling:

Active Ingredients

TITANIUM DIOXIDE 12%

Inactive Ingredient

Water, Ethylhexyl methoxycinnamte, Cyclomethicone, Cyclopentasiloxane, Hexyl Laurate, Butylene Glycol, Isodecyl neopentanoate, Amorphophallus Konjac Root Extract, Methyl Trimethicone, Bis-Ethylhexlyoxyphenol Methoxypehnyl Triazine, Polymethyl Met-hacrylate, C12-15 Alkyl Benzoate, Niacinamide, PEG-10 Dimethicone, Talc, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Nelumbo Nucifera Flower Extract, Jasminum Officinale (Jasmine) Flower/leaf Extract, Rose Extract, Lilium Candidum Bulb Extract, Freesia Refracta Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/leaf Extract, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Hyaluronic Acid, Sorbitan Isostearate, Dimethicone, Polysilicone-11, Ozokerite, Calcium Stearate, Lauryl PEG/PPG-18/18 Methicone, Glycerin, Triethoxycaprylylylsilane, Sorbitan Sesquioleate, Trihydroxysteain, Triethanolamine, Adenosine, Aluminum Hydroxide, Stearic Acid, Synthetic Fluorphlogopite, Silica Dimethyl Silylate, Zein, Zea Mays (Corn) Strach, Hydrogented Lecithin, Caprylic/capric Triglyceride, Disodium EDTA, CI 77491, CI 77492, CI 77499, Propylparaben, Methylparaben, Phenoxyethanol, Fragrance

When Using This Product

keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor

if rash occurs.

Keep Out of Reach of Children

If swallowed, get medical help or contact Poison Control Center right away.


Structured Label Content

Uses
  • Helps protect sunburns 
  • 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.
Purpose

Sunscreen

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water reistant sunscreen if swimming or sweating.
  • spending time in the sun increases your risk of skin cancer and early skin aging. To decrese this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other skin protection measures including: Sun Protection Measures
  • Limit time in the sun, especially from 10 am - 2 pm.
  • Wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months of age Ask  doctor.
Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Questions?

Call 646.328.6562

Other Information (Other information)
  • Protect the product in this container from excessive heat or direct sun.
Package Labeling:

Active Ingredients (Active ingredients)

TITANIUM DIOXIDE 12%

Inactive Ingredient

Water, Ethylhexyl methoxycinnamte, Cyclomethicone, Cyclopentasiloxane, Hexyl Laurate, Butylene Glycol, Isodecyl neopentanoate, Amorphophallus Konjac Root Extract, Methyl Trimethicone, Bis-Ethylhexlyoxyphenol Methoxypehnyl Triazine, Polymethyl Met-hacrylate, C12-15 Alkyl Benzoate, Niacinamide, PEG-10 Dimethicone, Talc, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Nelumbo Nucifera Flower Extract, Jasminum Officinale (Jasmine) Flower/leaf Extract, Rose Extract, Lilium Candidum Bulb Extract, Freesia Refracta Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/leaf Extract, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Hyaluronic Acid, Sorbitan Isostearate, Dimethicone, Polysilicone-11, Ozokerite, Calcium Stearate, Lauryl PEG/PPG-18/18 Methicone, Glycerin, Triethoxycaprylylylsilane, Sorbitan Sesquioleate, Trihydroxysteain, Triethanolamine, Adenosine, Aluminum Hydroxide, Stearic Acid, Synthetic Fluorphlogopite, Silica Dimethyl Silylate, Zein, Zea Mays (Corn) Strach, Hydrogented Lecithin, Caprylic/capric Triglyceride, Disodium EDTA, CI 77491, CI 77492, CI 77499, Propylparaben, Methylparaben, Phenoxyethanol, Fragrance

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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