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

Cellular Swiss Sunscreen by

Drug Labeling and Warnings

Cellular Swiss Sunscreen by is a Otc medication manufactured, distributed, or labeled by Temmentec Ag, Temmentec Ag . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients           Purpose

Octinoxate 7.5%            Sunscreen

Zinc Oxide 7.4%             Sunsceen

PURPOSE

Helps prevent sunburn

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

Warnings

-

- 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

DOSAGE & ADMINISTRATION

Directions

apply daily after cleansing and toning

Directions

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 hours

use 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

INACTIVE INGREDIENT

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)

PRINCIPAL DISPLAY PANEL

Cellular Swiss Ice Crystal Transforming Cream

Sunscreen

Broad Spectrum

SPF 30

50 ml / 1.7 FL OZ

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68807-313
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 78.4 kg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7.4 g  in 78.4 kg

Inactive Ingredients
Ingredient Name	Strength
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)
ALUMINUM OXIDE (UNII: LMI26O6933)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68807-313-11	78.4 kg in 1 DRUM; Type 0: Not a Combination Product	06/09/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/09/2015

Labeler - Temmentec Ag (480586411)

Registrant - Temmentec Ag (480586411)

Establishment
Name	Address	ID/FEI	Business Operations
Temmentec Ag		480586411	manufacture(68807-313)