LALINE RICH HAND CREAM- avobenzone, octocrylene lotion 
Emilia Cosmetics Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients

Avobenzone, 3.0%, Octocrylene, 10.0%

Purpose

Sunscreen

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: 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. If

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

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.

Other information •protect the product in this container from excessive heat

and direct sun.

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.

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LALINE  RICH HAND CREAM
avobenzone, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43219-002-3030 g in 1 TUBE; Type 0: Not a Combination Product06/05/201701/30/2020
2NDC:43219-002-10100 g in 1 TUBE; Type 0: Not a Combination Product06/05/201701/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/05/201701/30/2020
Labeler - Emilia Cosmetics Ltd (600076624)
Establishment
NameAddressID/FEIBusiness Operations
Emilia Resources, LLC079378421manufacture(43219-002) , pack(43219-002) , label(43219-002)

Revised: 6/2023
 
Emilia Cosmetics Ltd