CELLULAR SWISS SUNSCREEN BROAD SPECTRUM SPF 30- octinoxate, zinc oxide cream 
Temmentec Ag

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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Cellular Swiss Ice Crystal Transforming Cream SPF30 - BEIGE

Active Ingredients      Purpose

Octinoxate 7.5%     Sunscreen

Zinc Oxide 7.4%      Sunsceen

Helps prevent sunburn

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

Stop use and ask a doctor if rash occurs

- 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

Directions

apply daily after cleansing and toning

smooth over face & throat

apply liberally 15 minutes before sun exposure

Children under 6 months of age: Ask a doctor

Reapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweating

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:

Limit time in the sun, especially from 10 a.m. - 2 p.m.

Weare long-sleeve shirts, pants, hats and sunglasses

Water (Aqua), Isododecane, Dimethicone, Glycerin, Propylene Glycol, Polymethylsilsesquioxane, C12-15 Alkyl Benzoate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, PEG-15/LaurylPolydimethylsiloxyethyl Dimethicone Crosspolymer, PEG/PPG-18/18 Dimethicone, Glycoproteins*, Panax Ginseng Root Extract*, Equisetum Arvense Extract*, Saxifraga Oppositifolia Extract, Soldanella Alpina Extract, Chlamydomonas Extract, Bellis Pereniis (Daisy) Flower Extract, Lens Esculenta (Lentil Seed Extract, Sodium Hyaluronate, Panthenol, Magnesium Ascorbyl Phosphate, Tocopheryl Acetate, Tocopherol, Lecithin, Lactobacillus Ferment, Saccharomyces Cerevisiae Extract, Xanthan Gum, Tin Oxide, Disteardimonium Hectorite, Propylene Carbonate, Methicone, Dipropylene Glycol, Isomalt, Citric Acid, Lactic Acid, Maltodextrin, Triethoxycaprylylsilane, Alumina, Dimethicon Crosspolymer, Magnesium Sulfate, Sodim Citrate, Polyhydroxystearic Acid, BHT, Fragrance (Parfum), Alpha-Isomethyl Ionone, Benzyl Benzoate, Benzyl Salicylate, Butylphenyl Methylpropaional, Citonellol, Eugenol, Evernia Furfuracea (Treemoss) Extract, Geraniol, Hexyl Cinnamal, Hydroxycitronellal, Linalool, Phenoxyethanol, Ethylhexylglycerin, Potassium Sorbate

May Contain:

Mica (CI 77019), Titanium Dioxide (CI 77891), Titanium Dioxide (Nano), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Cellular Swiss Ice Crystal Transforming Cream

Sunscreen

Broad Spectrum

SPF 30

50 ml / 1.7 FL OZ

image description

image description

CELLULAR SWISS SUNSCREEN  BROAD SPECTRUM SPF 30
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68807-311
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 78.4 kg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION7.4 g  in 78.4 kg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)  
LENTIL (UNII: 6O38V6B52O)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PANTHENOL (UNII: WV9CM0O67Z)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ISOMALT (UNII: S870P55O2W)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LACTIC ACID (UNII: 33X04XA5AT)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
BENZYL BENZOATE (UNII: N863NB338G)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
EUGENOL (UNII: 3T8H1794QW)  
PSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K)  
GERANIOL (UNII: L837108USY)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68807-311-1178.4 kg in 1 DRUM; Type 0: Not a Combination Product06/10/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/10/2015
Labeler - Temmentec Ag (480586411)
Registrant - Temmentec Ag (480586411)
Establishment
NameAddressID/FEIBusiness Operations
Temmentec Ag480586411manufacture(68807-311)

Revised: 1/2017
Document Id: 86274685-4951-4a58-afbe-e7776d64557f
Set id: c7206e22-4db5-4cf9-a627-a85101017706
Version: 3
Effective Time: 20170109
 
Temmentec Ag