Laline Rich Hand Cream: Package Insert and Label Information

LALINE RICH HAND CREAM- avobenzone and 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.

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 Type HUMAN OTC DRUG Item Code (Source) NDC:43219-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
SHEA BUTTER
CYCLOMETHICONE 5
CYCLOMETHICONE 6
GLYCERIN
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
CETOSTEARYL ALCOHOL
JOJOBA OIL
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
SILICON DIOXIDE
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
.ALPHA.-TOCOPHEROL ACETATE
ALLANTOIN
PROPYLENE GLYCOL
HONEY
ALMOND
PENTYLENE GLYCOL
POLYOXYL 40 HYDROGENATED CASTOR OIL
TRIDECETH-9
SKIM MILK
ALMOND OIL
DECYLENE GLYCOL
1,2-HEXANEDIOL
TRIETHANOLAMINE BENZOATE
ALEURITES MOLUCCANA SEED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43219-002-30 30 g in 1 TUBE None
2 NDC:43219-002-10 100 g in 1 TUBE None
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 Operations
Emilia Resources, LLC 079378421 manufacture (43219-002), pack (43219-002), label (43219-002)

Revised: 01/2020 Emilia Cosmetics Ltd

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