Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2855a775-a1fe-4e8e-9dc4-7838ca1073e3
Route
TOPICAL
Published
Effective Date 2020-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (80 mg) Zinc Oxide (38 mg)
Inactive Ingredients
Aluminum Hydroxide Cyclomethicone 6 Cyclomethicone 5 Dimethicone 20 Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dimethiconol (2000 Cst) Lauryl Peg/ppg-18/18 Methicone Hydrogen Dimethicone (20 Cst) Peg-10 Dimethicone (600 Cst) Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-09-19

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

Purpose

Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen Sunscreen

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

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.

Purpose:

Sunscreen

Sunscreen

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 80 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 am-2 pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
  • Cleanse thoroughly at nighttime
  • PA++++
Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Principal Display Panel 53 G Bottle Label

ABBY SKIN CARE

ABBY ODIAMAR PACLIBAR

FLAWLESS

BRIGHTENING

SUNSCREEN

NON-TINTED

SPF 40 Broad Spectrum

Water Resistant (80 Minutes)

Oil Free Facial Mineral Sunscreen

Paraben Free

Reef Friendly

Net Wt 1.8 oz/53 g


Structured Label Content

Uses: (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.

Purpose: (PURPOSE:)

Sunscreen

Sunscreen

Warnings: (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: (DIRECTIONS:)
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 80 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 am-2 pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information: (OTHER INFORMATION:)
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
  • Cleanse thoroughly at nighttime
  • PA++++
Active Ingredients: (ACTIVE INGREDIENTS:)

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Principal Display Panel 53 G Bottle Label (Principal Display Panel - 53 g Bottle Label)

ABBY SKIN CARE

ABBY ODIAMAR PACLIBAR

FLAWLESS

BRIGHTENING

SUNSCREEN

NON-TINTED

SPF 40 Broad Spectrum

Water Resistant (80 Minutes)

Oil Free Facial Mineral Sunscreen

Paraben Free

Reef Friendly

Net Wt 1.8 oz/53 g


Advanced Ingredient Data


Raw Label Data

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