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

DERMAPROT by

Drug Labeling and Warnings

DERMAPROT by is a Otc medication manufactured, distributed, or labeled by SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Sunscreen lotion from wide spectrum sunscreen SPF 30

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

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

WARNINGS

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

Do not apply this product on under six months aged children

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

IMAGE OF THE CARTON LABEL 

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66854-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66854-026-01	10 mL in 1 BOTTLE
2	NDC: 66854-026-02	45 mL in 1 BOTTLE
3	NDC: 66854-026-03	70 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/30/2012

Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)

Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)

Establishment
Name	Address	ID/FEI	Business Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS		880172184	analysis(66854-026) , manufacture(66854-026) , label(66854-026) , pack(66854-026)