SPA SKILHA HELIOPROT AB SPF 40- bemotrizinol,octinoxate,avobenzone,titanium dioxide cream

SPA SKILHA by

Drug Labeling and Warnings

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

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

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

WARNINGS

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

IMAGE OF THE LABEL 

INGREDIENTS AND APPEARANCE

SPA SKILHA   HELIOPROT AB SPF 40
bemotrizinol,octinoxate,avobenzone,titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66854-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH)	BEMOTRIZINOL	1.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66854-025-01	9 g in 1 JAR
2	NDC: 66854-025-02	33 g in 1 JAR
3	NDC: 66854-025-03	60 g in 1 TUBE
4	NDC: 66854-025-05	20 in 1 BOX
4	NDC: 66854-025-04	15 g in 1 TUBE

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, label, manufacture, pack