LIPIDOL- avobenzone, homosalate, octisalate, octocrylene oil 
UNION-SWISS (PTY) 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                              Purpose

Avobenzone 3%

Homosalate 6%

Octisalate 5%

Octocrylene 6.5% ............................... Sunscreen

Uses

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Lipidol 

Sunscreen Broad Spectrum SPF 20

4.2 fl. oz.

Directions
apply liberally 15 minutes before sun exposure
reapply:

use a water resistant sunscreen if swimming or sweating
children under 6 months: 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:

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.

Inactive Ingredients

mineral oil (paraffinum liquidum), isopropyl palmitate, cetearyl ethylhexanoate, C12-15 alkyl benzoate, oryxanol, bisabolol, tocopheryl acetate, pyridoxine dipalmitate, octyldodecyl PCA, phytosterols, carthamus tinctorius (safflower) seed oil, borago officinalis (borage) seed oil, linoleic acid, linolenic acid, butylene glycol, BHT, cupressus simpervirens oil, ocimum basilicum (basil) oil, melia azadirachta leaf extract, melia azadirachta flower extract, aspartic acid, arginine, glycine, glutamic acid, histidine, coccinia indica fruit extract, solanum melongena (eggplant) fruit extract, aloe barbadensis flower extract, lawsonia inermis (henna) flower/fruit/leaf extract, ocimum sanctum leaf extract, ocimum basilicum (basil) flower/leaf extract, curcuma longa (turmeric) root extract, corallina officinalis extract, simmondsia chinensis (jojoba) seed oil, farnesol, limonene

image description

LIPIDOL 
avobenzone, homosalate, octisalate, octocrylene oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69359-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
GAMMA ORYZANOL (UNII: SST9XCL51M)  
LEVOMENOL (UNII: 24WE03BX2T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PYRIDOXINE DIPALMITATE (UNII: HB49XCT029)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SAFFLOWER SEED (UNII: 8FCL6A31TX)  
BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
LINOLENIC ACID (UNII: 0RBV727H71)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)  
OCIMUM BASILICUM WHOLE (UNII: P4815JL4O3)  
AZADIRACHTA INDICA WHOLE (UNII: MRL4DVG1F6)  
ASPARTIC ACID (UNII: 30KYC7MIAI)  
ARGININE (UNII: 94ZLA3W45F)  
GLYCINE (UNII: TE7660XO1C)  
GLUTAMIC ACID (UNII: 3KX376GY7L)  
HISTIDINE (UNII: 4QD397987E)  
COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)  
SOLANUM MELONGENA WHOLE (UNII: 5DS5EE0N93)  
ALOE VERA FLOWER (UNII: 575DY8C1ER)  
LAWSONIA INERMIS WHOLE (UNII: W7M7338R56)  
OCIMUM TENUIFLORUM WHOLE (UNII: 7OS52KZ33J)  
CURCUMA LONGA WHOLE (UNII: W5488JUO8U)  
CORALLINA OFFICINALIS (UNII: 4004498D06)  
JOJOBA OIL (UNII: 724GKU717M)  
FARNESOL (UNII: EB41QIU6JL)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69359-000-00125 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/07/2014
Labeler - UNION-SWISS (PTY) LTD (568517499)
Establishment
NameAddressID/FEIBusiness Operations
COLUMBIA PHARMACEUTICALS (PTY) LTD539147769manufacture(69359-000)

Revised: 11/2015
Document Id: e7c5fce0-d31f-4114-b8ea-610bef25431a
Set id: a500a64b-319f-476f-ac38-1648b587acf5
Version: 2
Effective Time: 20151124
 
UNION-SWISS (PTY) LTD