DERMAPROT HELIOPROT AB SPF 30- octinoxate,titanium dioxide,oxybenzone,avobenzone lotion 
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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DERMAPROT HELIOPROT LOCION ANTISOLAR SPF 30

ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, BUTYL METHOXYDIBENZOYLMETHANE, BENZOPHENONE-3, are a set of physical and chemical filters that provide SPF 30

Sunscreen lotion from wide spectrum sunscreen SPF 30

Keep out of reach of children

Provides moderate protection against sun. This product is for topical application.

Avoid the contact with eyes, rinse with water to remove.

Do not apply this product on under six months aged children

Rub to cover the area to be protected and wait for its full absorption

Solar protector UVA UVB has an aqeous base where we deposited all the active ingredients to garantee a wide range of the sun protection; rehydrates the skin tissues maintining cellular bioactivity without the inconvenient of the oily foundations.

IMAGE OF THE CARTON LABEL  IMAGE OF THE CARTON LABEL

DERMAPROT  HELIOPROT AB SPF 30
octinoxate,titanium dioxide,oxybenzone,avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-026
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMOMILE (UNII: FGL3685T2X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66854-026-0110 mL in 1 BOTTLE
2NDC:66854-026-0245 mL in 1 BOTTLE
3NDC:66854-026-0370 mL in 1 BOTTLE
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(66854-026) , manufacture(66854-026) , label(66854-026) , pack(66854-026)

Revised: 6/2012
Document Id: 3aa210bd-65ec-411f-9328-2dc7ae4cd504
Set id: 1121cb01-8d2f-4b80-a86f-0f4b18ff34d6
Version: 1
Effective Time: 20120607
 
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS