LBRI PURE N NATURAL SPF 30- zinc oxide cream

LBri Pure n Natural SPF 30 by

Drug Labeling and Warnings

LBri Pure n Natural SPF 30 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

Zinc Oxide 19%

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 ealy 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

1,2-Hexanediol, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Beeswax, Caprylic/Capric Triglyceride, Chamomilla Recutita (Chamomile) Extract, Citrus Aurantium Dulcis (Orange) Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limonum (Lemon) Oil, Citrus Reticulata (Tangerine) Extract, Coco-Caprylate, Decylene Glycol, Ethylhexyl Palmitate, Gluconolactone, Glycerin, Hydrogenated Castor Oil, Isopropyl Myristate, Isopropyl Palmitate, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Lonicera Caprifolium (Honeysuckle) Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Magnesium Sulfate, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Populus Tremuloides Bark Extract, Salix Nigra (Willow) Bark Extract, Silica, Sodium Chloride, Stearic Acid.

Other Information:

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

Package Labeling:

INGREDIENTS AND APPEARANCE

LBRI PURE N NATURAL SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71238-326
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	190 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CHAMOMILE (UNII: FGL3685T2X)
ORANGE (UNII: 5EVU04N5QU)
ORANGE OIL (UNII: AKN3KSD11B)
LEMON (UNII: 24RS0A988O)
TANGERINE (UNII: KH3E3096OO)
COCO-CAPRYLATE (UNII: 4828G836N6)
DECYLENE GLYCOL (UNII: S57M60MI88)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71238-326-00	118 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2018

Labeler - L'BRI HEALTH & BEAUTY (139751148)