SPA SKILHA  HELIOPROT AB SPF 40- bemotrizinol,octinoxate,avobenzone,titanium dioxide cream 
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

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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SPA SKILHA HELIOPROT AB SPF 40

Ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, titanium dioxide and bis-ethylhexyl oxyphenol methoxyphenyl triazine offers total protection and wide spectrum against the UVA and UVB.

As dermoprotective solar screen, moisturizes and nourishes. Delays photo-aging and prevents skin cancer.

Keep out of reach of children

Use this product when you exposed to the sun. SPF 40 UVA / UVB

Avoid contact with eyes, do not use in the children under (6) six months of age.

- Apply generously before sun exposure.
- Reapply after (6) six hours.

Its composition is photo stable, perfectly adjusted to any state and any contidtion of the skin.

IMAGE OF THE LABEL  IMAGE OF THE LABEL

SPA SKILHA   HELIOPROT AB SPF 40
bemotrizinol,octinoxate,avobenzone,titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL1.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)  
WHEAT GERM OIL (UNII: 14C97E680P)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66854-025-019 g in 1 JAR
2NDC:66854-025-0233 g in 1 JAR
3NDC:66854-025-0360 g in 1 TUBE
4NDC:66854-025-0520 in 1 BOX
4NDC:66854-025-0415 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/30/2012
Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Establishment
NameAddressID/FEIBusiness Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, label, manufacture, pack

Revised: 6/2012
Document Id: 469199f3-6194-4eda-8351-c99130f06299
Set id: ff3ef5f7-4846-48c6-aebc-26723f7f2320
Version: 1
Effective Time: 20120607
 
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS