FRESH SKIN EFFORTLESS BEAUTY BALM BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide cream 
AERIN LAUDER BEAUTY DIST.

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.

----------

FRESH SKIN EFFORTLESS BEAUTY BALM BROAD SPECTRUM SPF 35

Drug Facts

Active ingredientsPurpose
Octinoxate 7.50%Sunscreen
Octisalate 4.00%Sunscreen
Oxybenzone 2.50%Sunscreen
Titanium Dioxide 1.10%Sunscreen
Zinc Oxide 3.30%Sunscreen

Use

helps prevent sunburn

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

Inactive ingredients

water\aqua\eau • dimethicone • butylene glycol • phenyl trimethicone • pentylene glycol • glyceryl stearate • behenyl alcohol • trioctyldodecyl citrate • polymethylsilsesquioxane • octyldodecyl stearoyl stearate • peg-40 stearate • polyglyceryl-10 pentastearate • tocopheryl acetate • sodium hyaluronate • lecithin • squalane • triticum vulgare (wheat) germ extract • hordeum vulgare (barley) extract\extrait d'orge • cucumis sativus (cucumber) fruit extract • laminaria saccharina extract • pyrus malus (apple) fruit extract • scutellaria baicalensis root extract • glycerin • caffeine • cholesterol • oryzanol • trehalose • octyldodecyl neopentanoate • polyglyceryl-6 polyricinoleate • acetyl hexapeptide-8 • sodium pca • sucrose • urea • polyquaternium-51 • sodium stearoyl lactylate • ammonium acryloyldimethyltaurate/vp copolymer • polysorbate 20 • sorbitan laurate • propylene glycol laurate • glycyrrhetinic acid • linoleic acid • stearic acid • xanthan gum • silica • isopropyl titanium triisostearate • alumina • propylene glycol stearate • disodium edta • sodium dehydroacetate • chlorphenesin • phenoxyethanol • [+/- mica • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499) • titanium dioxide (ci 77891)] <iln41064>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

AERIN

FRESH SKIN
EFFORTLESS BEAUTY BALM
BROAD SPECTRUM SPF 35

1.7 FL. OZ. LIQ/50ml e

Principal Display Panel - 50 ml Tube Carton
FRESH SKIN EFFORTLESS BEAUTY BALM BROAD SPECTRUM SPF 35 
octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43072-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.08175 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0436 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02725 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.01199 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.03597 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
dimethicone (UNII: 92RU3N3Y1O)  
butylene glycol (UNII: 3XUS85K0RA)  
phenyl trimethicone (UNII: DR0K5NOJ4R)  
pentylene glycol (UNII: 50C1307PZG)  
glyceryl monostearate (UNII: 230OU9XXE4)  
docosanol (UNII: 9G1OE216XY)  
trioctyldodecyl citrate (UNII: 35X8CT063R)  
octyldodecyl stearoyl stearate (UNII: 3D47Q6D93C)  
peg-40 stearate (UNII: ECU18C66Q7)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
squalane (UNII: GW89575KF9)  
wheat germ (UNII: YR3G369F5A)  
barley (UNII: 5PWM7YLI7R)  
cucumber (UNII: YY7C30VXJT)  
saccharina latissima (UNII: 68CMP2MB55)  
apple (UNII: B423VGH5S9)  
scutellaria baicalensis root (UNII: 7J95K7ID2S)  
glycerin (UNII: PDC6A3C0OX)  
caffeine (UNII: 3G6A5W338E)  
cholesterol (UNII: 97C5T2UQ7J)  
gamma oryzanol (UNII: SST9XCL51M)  
trehalose (UNII: B8WCK70T7I)  
octyldodecyl neopentanoate (UNII: X8725R883T)  
acetyl hexapeptide-8 (UNII: L4EL31FWIL)  
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)  
sucrose (UNII: C151H8M554)  
urea (UNII: 8W8T17847W)  
sodium stearoyl lactylate (UNII: IN99IT31LN)  
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)  
polysorbate 20 (UNII: 7T1F30V5YH)  
sorbitan monolaurate (UNII: 6W9PS8B71J)  
propylene glycol monolaurate (UNII: 668Z5835Z3)  
enoxolone (UNII: P540XA09DR)  
linoleic acid (UNII: 9KJL21T0QJ)  
stearic acid (UNII: 4ELV7Z65AP)  
xanthan gum (UNII: TTV12P4NEE)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
isopropyl titanium triisostearate (UNII: 949E3KBJ1I)  
aluminum oxide (UNII: LMI26O6933)  
propylene glycol stearate (UNII: MZM1I680W0)  
edetate disodium (UNII: 7FLD91C86K)  
sodium dehydroacetate (UNII: 8W46YN971G)  
chlorphenesin (UNII: I670DAL4SZ)  
phenoxyethanol (UNII: HIE492ZZ3T)  
mica (UNII: V8A1AW0880)  
ferric oxide red (UNII: 1K09F3G675)  
ferric oxide yellow (UNII: EX438O2MRT)  
ferrosoferric oxide (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43072-001-011 in 1 CARTON
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/01/2014
Labeler - AERIN LAUDER BEAUTY DIST. (078518500)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(43072-001) , REPACK(43072-001)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(43072-001) , REPACK(43072-001)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(43072-001)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(43072-001)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(43072-001)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(43072-001)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(43072-001) , REPACK(43072-001)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC LLC959338336MANUFACTURE(43072-001)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(43072-001) , REPACK(43072-001)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(43072-001)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(43072-001)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center (PALC)078364654REPACK(43072-001) , RELABEL(43072-001)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(43072-001)

Revised: 12/2014
Document Id: 18412891-9023-4e11-930b-75efe3bc9340
Set id: 0db9148d-e1bd-46b9-925f-1952da4e1b0b
Version: 1
Effective Time: 20141219
 
AERIN LAUDER BEAUTY DIST.