RECLARX MOISTURE SHIELD- octocrylene and avobenzone cream

Reclarx Moisture Shield by

Drug Labeling and Warnings

Reclarx Moisture Shield by is a Otc medication manufactured, distributed, or labeled by NBC Aesthetics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octocrylene 7%, Butyl Methoxydibenzoylmethane 2%

Purpose

Sunscreen

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.

Warnings

For external use only.

Do not use on damage or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally to face and neck after Step 3 at least 15 minutes before sun exposure.

• Use a water resistant sunscreen if swimming or sweating
• reapply immediately after towel drying
• at least every 2 hours.

Sun Protection Measures:

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10am-2pm
• wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Bambusa Vulgaris (Bamboo) Leaf/Stem Extract, Butylene Glycol, Butyrospermum Parkii (Shea Butter), Calendula Officinalis Seed Oil, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Cera Alba (Beeswax), Cetyl Alcohol, Dimethicone, Fragrance (Perfume), Glycerin, Glyceryl Stearate SE, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Extract, Maris Aqua (Dead Sea Water), Nordihydroguaiaretic Acid, Peg-40 Stearate, Olea Europaea (Olive) Fruit Oil, Oleanolic Acid, Peg-60 Almond Glycerides, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Rosa Canina Fruit, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salicylic Acid, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Triethylene Glycol, Vitis Vinifera (Grape) Seed Oil, Water.

Questions or Comments:

Call 1-800-397-7191, Mon-Fri

Principal Display Panel - Bottle Label

Reclarx™ BD

Blemish-Defying Regimen

All Skin Types

Moisture Shield

Sunscreen

Broad Spectrum

SPF 15

STEP
4

AM/PM

Locks In moisture and provides UVA/UVB
protection against the elements

DERMATOLOGIST TESTED NOT TESTED ON ANIMALS

Exclusively distributed by: NBC Aesthetics, LLC 23715 Mercantile Road Beachwood, Ohio 44122 info@reclarx.com www.reclarx.com

INGREDIENTS AND APPEARANCE

RECLARX MOISTURE SHIELD 
octocrylene and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61402-7131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GRAPE SEED OIL (UNII: 930MLC8XGG)
SALICYLIC ACID (UNII: O414PZ4LPZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
MASOPROCOL (UNII: 7BO8G1BYQU)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
WHITE WAX (UNII: 7G1J5DA97F)
PEG-40 STEARATE (UNII: ECU18C66Q7)
COCOA BUTTER (UNII: 512OYT1CRR)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
JOJOBA OIL (UNII: 724GKU717M)
DIMETHICONE (UNII: 92RU3N3Y1O)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
OLIVE OIL (UNII: 6UYK2W1W1E)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
ROSEMARY (UNII: IJ67X351P9)
AVOCADO OIL (UNII: 6VNO72PFC1)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61402-7131-1	50 mL in 1 BOTTLE; 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	06/01/2015

Labeler - NBC Aesthetics, LLC (078882808)