Defense Broad Spectrum Spf 25 Sunscreen

Defense Broad Spectrum Spf 25 Sunscreen
SPL v2
SPL
SPL Set ID f80fc7be-082f-8a23-e053-6394a90a6278
Route
TOPICAL
Published
Effective Date 2023-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7 g) Zinc Oxide (6 g)
Inactive Ingredients
Water Isocetyl Stearate Sorbitol Ethyl Macadamiate Cetostearyl Alcohol Dimethicone Phenoxyethanol Glyceryl Monostearate Glycerin Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Peg-100 Stearate Polyoxyl 20 Cetostearyl Ether Octisalate Xanthan Gum Poly(methyl Methacrylate; 450000 Mw) Caprylyl Glycol Ethylhexylglycerin Lingonberry Quercus Suber Bark Triethoxycaprylylsilane Green Tea Leaf Edetate Disodium Anhydrous .alpha.-tocopherol Acetate Centella Asiatica Whole Polygonum Aviculare Top Citric Acid Monohydrate Gluconolactone Isomalt Calcium Gluconate Sodium Benzoate Garden Cress Sprout

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-03-01

Description

DRUG FACTS:

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

DRUG FACTS:

Uses

Helps prevent sunburn.

Section 42229-5

DRUG FACTS:

Section 50565-1

Keep out of reach of children.

Warnings

For external use only. Do not use on damaged or broken skin . When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

Directions

Apply to all skin exposed to the sun.

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • For children under 6 months of age: 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 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.
Other Information

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Octinoxate 7.0%, Zinc Oxide 6.0%.

Inactive Ingredients

Water, Isocetyl Stearate, Cetyl Dimethicone, Styrene/Acrylates Copolymer, Sorbitol, Ethyl Macadamiate, Cetearyl Alcohol, Dimethicone, Acrylates/Dimethicone Copolymer, Phenoxyethanol, Glyceryl Stearate, Glycerin, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, PEG-100 Stearate, Ceteareth-20, Ethylhexyl Salicylate, VP/Eicosene Copolymer, Xanthan Gum, Polymethyl Methacrylate, Caprylyl Glycol, Cocos Nucifera Oil, Ethylhexylglycerin, Vaccinium Vitis-Idaea Fruit Extract, Quercus Suber Bark Extract, Triethoxycaprylylsilane, Camellia Sinensis Leaf Extract, Disodium EDTA, Tocopheryl Acetate, Oak Root Extract, Centella Asiatica Extract, Polygonum Aviculare Extract, Citric Acid, Gluconolactone, Isomalt, Calcium Gluconate, Lecithin, Vitis Vinifera Fruit Cell Extract, Sodium Benzoate, Lepidium Sativum Sprout Extract.

Principal Display Panel

Defense Broad Spectrum SPF 25 Sunscreen


Structured Label Content

Uses (USES)

Helps prevent sunburn.

Section 42229-5 (42229-5)

DRUG FACTS:

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose (PURPOSE)

Sunscreen

Warnings (WARNINGS)

For external use only. Do not use on damaged or broken skin . When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

Directions (DIRECTIONS)

Apply to all skin exposed to the sun.

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • For children under 6 months of age: 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 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.
Other Information (OTHER INFORMATION)

Protect the product in this container from excessive heat and direct sun.

Active Ingredients (ACTIVE INGREDIENTS)

Octinoxate 7.0%, Zinc Oxide 6.0%.

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Isocetyl Stearate, Cetyl Dimethicone, Styrene/Acrylates Copolymer, Sorbitol, Ethyl Macadamiate, Cetearyl Alcohol, Dimethicone, Acrylates/Dimethicone Copolymer, Phenoxyethanol, Glyceryl Stearate, Glycerin, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, PEG-100 Stearate, Ceteareth-20, Ethylhexyl Salicylate, VP/Eicosene Copolymer, Xanthan Gum, Polymethyl Methacrylate, Caprylyl Glycol, Cocos Nucifera Oil, Ethylhexylglycerin, Vaccinium Vitis-Idaea Fruit Extract, Quercus Suber Bark Extract, Triethoxycaprylylsilane, Camellia Sinensis Leaf Extract, Disodium EDTA, Tocopheryl Acetate, Oak Root Extract, Centella Asiatica Extract, Polygonum Aviculare Extract, Citric Acid, Gluconolactone, Isomalt, Calcium Gluconate, Lecithin, Vitis Vinifera Fruit Cell Extract, Sodium Benzoate, Lepidium Sativum Sprout Extract.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Defense Broad Spectrum SPF 25 Sunscreen


Advanced Ingredient Data


Raw Label Data

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