ORCHIDEE DOUBLE DEFENSE SKIN SHIELD- octinoxate, homosalate, octisalate, oxybenzone and avobenzone cream

Orchidee Double Defense Skin Shield by

Drug Labeling and Warnings

Orchidee Double Defense Skin Shield by is a Otc medication manufactured, distributed, or labeled by Lionesse USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

Purpose

Sunscreen

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.

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.

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.

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.

Package/Label Principal Display Panel

PEARL DE
FLORÉ

ORCHIDÉE DOUBLE DEFENSE SKIN SHIELD
SPF 30 BROAD SPECTRUM
Orchidèe Bouclier Double Dèfense SPF 30
50g / 1.76oz

FLORÉ DE ORCHIDÉE

CONTAINS ORGANIC INGREDIENTS

2450 HOLLYWOOD BLVD #703
HOLLYWOOD, FL 33020
WWW.PEARLDEFLORE.COM

Label

INGREDIENTS AND APPEARANCE

ORCHIDEE DOUBLE DEFENSE SKIN SHIELD 
octinoxate, homosalate, octisalate, oxybenzone and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72104-588
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.4 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.1 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
TOCOPHEROL (UNII: R0ZB2556P8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
ROSEMARY (UNII: IJ67X351P9)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72104-588-14	1 in 1 CARTON	08/27/2021
1		50 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/27/2021

Labeler - Lionesse USA, Inc. (079661431)