Label: CELLULAR SWISS SUNSCREEN BROAD SPECTRUM SPF 30- octinoxate, zinc oxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 68807-312-11 - Packager: Temmentec Ag
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 4, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
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
-
INGREDIENTS AND APPEARANCE
CELLULAR SWISS SUNSCREEN BROAD SPECTRUM SPF 30
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68807-312 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:68807-312-11 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(68807-312)
