LBRI PURE NNATURAL OIL FREE MOISTURIZER- octinoxate, avobenzone, octisalate cream

LBri Pure nNatural Oil Free Moisturizer by

Drug Labeling and Warnings

LBri Pure nNatural Oil Free Moisturizer by is a Otc medication manufactured, distributed, or labeled by L'Bri Health & Beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredients:

Octinoxate 7.50%

Avobenzone 3.00%

Octisalate 3.00%

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 damaged or broken skin.

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and consult physician 

if irritation or rash develops.

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediately.

DIRECTIONS:

• Apply liberally 15-minutes before sun exposure.
• Reapply:

   -At least every two-hours.

   Immediately after swimming, sweating or towel drying.

SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

• Limit time in the sun, especially between 10am and 2pm.
• Wear long sleeve shirts, pants, hats and sunglasses.
• For children under 6-months, consult a physician.

OTHER INGREDIENTS:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bee Pollen Extract, C12-15 Alkyls Benzoate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Carbomer, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Dimethicone, Disodium EDTA, Equisetum Arvense (Horsetail) Extract, Ethylhexylglycerin, Glyceryl Stearate, Hypericum Perforatum (St. John's Wort) Extract, Melissa Officinalis (Mint Balm) Extract, PEG-100 Stearate, Phenoxyethanol, Pinus Pinaster (Pine) Needle Extract, Pinus Strobus (Pine) Bark Extract, Polysorbate-20, Stearic Acid, Symphytum Officinale (Comfrey) Extract, Triethanolamine.

Other Information:

• Protect this product from excessive heat and direct sunlight.

Package Labeling:

INGREDIENTS AND APPEARANCE

LBRI PURE NNATURAL OIL FREE MOISTURIZER 
octinoxate, avobenzone, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71238-785
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHAMOMILE (UNII: FGL3685T2X)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
MELISSA OFFICINALIS (UNII: YF70189L0N)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PINUS STROBUS BARK (UNII: 8PJ4761097)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71238-785-18	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/07/2017

Labeler - L'Bri Health & Beauty (139751148)