Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f4a34add-2791-43a0-8bf9-e96b5c75f167
Route
TOPICAL
Published
Effective Date 2021-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (30 mg) Zinc Oxide (100 mg)
Inactive Ingredients
Butyloctyl Salicylate Alkyl (c12-15) Benzoate Caprylhydroxamic Acid Caprylyl Glycol Carboxymethylcellulose Sodium, Unspecified Form Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Citric Acid Monohydrate Edetate Disodium Anhydrous Glycereth-26 Glycerin Glyceryl Monostearate Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Microcrystalline Cellulose Octyldodecyl Neopentanoate Polyhydroxystearic Acid (2300 Mw) Poly(methyl Methacrylate; 450000 Mw) Polysorbate 80 1,3,3,3-tetrafluoropropene, (1e)- Tricontanyl Povidone Triethoxycaprylylsilane Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-04-24

Description

Titanium Dioxide 3% Zinc Oxide 10%

Purpose

Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen Sunscreen

Description

Titanium Dioxide 3% Zinc Oxide 10%

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:
  • Shake well before using.
  • Push nozzle up to release safety tab.
  • 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 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
  • Store between 68° to 104° F (20° to 40° C).
  • Do not store at temperatures above 120° F.
Active Ingredients:

Titanium Dioxide 3%

Zinc Oxide 10%

Inactive Ingredients:

Butyloctyl Salicylate, Cl2-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth 20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Methyl Methacrylate Crosspolymer, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polymethyl Methacrylate, Polysorbate 80, Polyurethane-2, Trans-1,3,3,3-Tetrafluoropropene, Tricontanyl PVP, Triethoxycaprylylsilane, Trimethoxycaprylylsilane, Water

Principal Display Panel 100 G Can Label

ABBY SKIN CARE

ABBY ODIAMAR PACLIBAR

FACE & BODY

MINERAL SPF

NON-TINTED

Oil Free Mousse Sunscreen

broad spectrum SPF 30

water resistant (40 mins)

  • Great for all skin types
  • Photo-stable will not degrade in sunlight
  • FREE of chemical sunscreen filters, dyes,

    fragrances, oils and preservatives
  • Reef friendly
  • non-comedogenic

3.5 oz | 100 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:)
  • Shake well before using.
  • Push nozzle up to release safety tab.
  • 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 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
  • Store between 68° to 104° F (20° to 40° C).
  • Do not store at temperatures above 120° F.
Active Ingredients: (ACTIVE INGREDIENTS:)

Titanium Dioxide 3%

Zinc Oxide 10%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Butyloctyl Salicylate, Cl2-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth 20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Methyl Methacrylate Crosspolymer, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polymethyl Methacrylate, Polysorbate 80, Polyurethane-2, Trans-1,3,3,3-Tetrafluoropropene, Tricontanyl PVP, Triethoxycaprylylsilane, Trimethoxycaprylylsilane, Water

Principal Display Panel 100 G Can Label (Principal Display Panel - 100 g Can Label)

ABBY SKIN CARE

ABBY ODIAMAR PACLIBAR

FACE & BODY

MINERAL SPF

NON-TINTED

Oil Free Mousse Sunscreen

broad spectrum SPF 30

water resistant (40 mins)

  • Great for all skin types
  • Photo-stable will not degrade in sunlight
  • FREE of chemical sunscreen filters, dyes,

    fragrances, oils and preservatives
  • Reef friendly
  • non-comedogenic

3.5 oz | 100 g


Advanced Ingredient Data


Raw Label Data

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