LALINE RICH HAND CREAM- avobenzone, octocrylene lotion

Laline by

Drug Labeling and Warnings

Laline by is a Otc medication manufactured, distributed, or labeled by Emilia Cosmetics Ltd, Emilia Resources, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone, 3.0%, Octocrylene, 10.0%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses helps prevent sunburn  if used as directedwith other skin protection

measures (see Directions), decreases the risk of skin cancer and early skin

aging caused by the sun.

WARNINGS

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 ask a doctor  if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If

swallowed, get medical help or contact a Poison control Center right away.

DOSAGE & ADMINISTRATION

Directions:  apply liberally 15 minutes before sun exposure. reapply at

least every 2 hours use water resistant sunscreen if swimming or sweating.

children under 6 months of age: ask a doctor. 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.

STORAGE AND HANDLING

Other information protect the product in this container from excessive heat

and direct sun.

INACTIVE INGREDIENT

Inactive ingredients  water, butyrospermum parkii (shea butter), cyclopentasiloxane, cyclohexasiloxane, glycerin, glyceryl stearate,

PEG-100 stearate, cetearyl alcohol, simmondsia chinensis (jojoba) seed oil, phenoxyethanol, ethylhexylglycerin,

fragrance, silica, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer,

tocopheryl acetate (vitamin E), allantoin, propylene glycol, honey extract, prunus amygdalus dulcis (sweet almond) seed extract, pentylne

glycol,PEG-40 hydrogenated castor oil, trideceth-9, nonfat dry milk, prunus amygdalus dulcis (sweet almond) oil, decylene glycol,

1,2-hexanediol, triethanolamine, aleurites moluccanus seed oil.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LALINE  RICH HAND CREAM
avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43219-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
JOJOBA OIL (UNII: 724GKU717M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HONEY (UNII: Y9H1V576FH)
ALMOND (UNII: 3Z252A2K9G)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
TRIDECETH-9 (UNII: X9HD79I514)
SKIM MILK (UNII: 6A001Y4M5A)
ALMOND OIL (UNII: 66YXD4DKO9)
DECYLENE GLYCOL (UNII: S57M60MI88)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)
ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43219-002-30	30 g in 1 TUBE; Type 0: Not a Combination Product	06/05/2017
2	NDC: 43219-002-10	100 g in 1 TUBE; Type 0: Not a Combination Product	06/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/05/2017

Labeler - Emilia Cosmetics Ltd (600076624)

Establishment
Name	Address	ID/FEI	Business Operations
Emilia Resources, LLC		079378421	manufacture(43219-002) , pack(43219-002) , label(43219-002)