Orchidèe Double Defense Skin Shield Cream

Orchidèe Double Defense Skin Shield Cream
SPL v3
SPL
SPL Set ID 74b3c33f-5db5-460d-97be-fa495b625249
Route
TOPICAL
Published
Effective Date 2025-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.4 g) Homosalate (6.2 g) Octisalate (5.0 g) Oxybenzone (3.1 g) Avobenzone (1.5 g)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Glycerin Glyceryl Monostearate Stearic Acid Peg-100 Monostearate Phenoxyethanol Ethylhexylglycerin Polysorbate 60 Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Carbomer Homopolymer, Unspecified Type Trolamine Tocopherol Vitamin A Palmitate Aloe Vera Leaf Green Tea Leaf Sodium Pyrrolidone Carboxylate Rosa Canina Fruit Rosemary Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-08-27 Until 2024-12-31

Description

Octinoxate 7.40% Homosalate 6.20% Octisalate 5.00% Oxybenzone 3.10% Avobenzone 1.50%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.40% Homosalate 6.20% Octisalate 5.00% Oxybenzone 3.10% Avobenzone 1.50%

Uses
  • Helps prevent sunburn.
Warnings

For external use only. Do not use on damaged or broken skin.

Keep out of eyes. If contact occurs, rinse with water. If rash or irritation develops, discontinue use and consult your physician.

Directions
  • After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results.
  • Reapply at least every two (2) hours.
  • Use water resistant sunscreen if swimming or sweating.

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.

For children under 6 months of age: Ask doctor.

Other Information

Protect the product in this container from excessive heat and direct sun. Store at room temperature.

Active Ingredients

Octinoxate 7.40%

Homosalate 6.20%

Octisalate 5.00%

Oxybenzone 3.10%

Avobenzone 1.50%

Inactive Ingredients

Aqua/Water/Eau, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate, Stearic Acid, PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 60, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Triethanolamine, Fragrance, Tocopherol, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, Camellia Sinensis Extract, Sodium PCA, Orchid Extract, Organic Rosa Canina Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Disodium EDTA.

Stop Using This Product
  •  
    and ask doctor if rash or redness develops and lasts.
Keep Out of Reach of Children.

If accidental ingestion, call the Poison Control Center right away.

Package/label Principal Display Panel – 62g Jar Label

PEARL DE

FLORÉ



ORCHIDÉE DOUBLE DEFENSE SKIN SHIELD

SPF 30 BROAD SPECTRUM

Orchidèe Bouclier Double Dèfense SPF 30

62g / 2.2oz

FLORÉ DE ORCHIDÉE



CONTAINS ORGANIC INGREDIENTS



2450 HOLLYWOOD BLVD #703

HOLLYWOOD, FL 33020

WWW.PEARLDEFLORE.COM


Structured Label Content

Uses
  • Helps prevent sunburn.
Purpose

Sunscreen

Warnings

For external use only. Do not use on damaged or broken skin.

Keep out of eyes. If contact occurs, rinse with water. If rash or irritation develops, discontinue use and consult your physician.

Directions
  • After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results.
  • Reapply at least every two (2) hours.
  • Use water resistant sunscreen if swimming or sweating.

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.

For children under 6 months of age: Ask doctor.

Other Information

Protect the product in this container from excessive heat and direct sun. Store at room temperature.

Active Ingredients

Octinoxate 7.40%

Homosalate 6.20%

Octisalate 5.00%

Oxybenzone 3.10%

Avobenzone 1.50%

Inactive Ingredients

Aqua/Water/Eau, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate, Stearic Acid, PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 60, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Triethanolamine, Fragrance, Tocopherol, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, Camellia Sinensis Extract, Sodium PCA, Orchid Extract, Organic Rosa Canina Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Disodium EDTA.

Stop Using This Product (Stop using this product)
  •  
    and ask doctor if rash or redness develops and lasts.
Keep Out of Reach of Children. (Keep out of reach of children.)

If accidental ingestion, call the Poison Control Center right away.

Package/label Principal Display Panel – 62g Jar Label (PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 62g JAR LABEL)

PEARL DE

FLORÉ



ORCHIDÉE DOUBLE DEFENSE SKIN SHIELD

SPF 30 BROAD SPECTRUM

Orchidèe Bouclier Double Dèfense SPF 30

62g / 2.2oz

FLORÉ DE ORCHIDÉE



CONTAINS ORGANIC INGREDIENTS



2450 HOLLYWOOD BLVD #703

HOLLYWOOD, FL 33020

WWW.PEARLDEFLORE.COM


Advanced Ingredient Data


Raw Label Data

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