Label: LINE INTERCEPTION POWER DUO DAY CREAM SUNCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68807-326-11, 68807-326-22, 68807-326-33 - 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 5, 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
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DOSAGE & ADMINISTRATION
Directions
- apply daily after cleansing and toning
- smooth over face & throat
- apply liberally 15 minutes before sun exposure
- children und 6 months of age: Ask a doctor
- reapply at least every 2 hours
- use a water resistan sunscreen if swimming or sweating
- Sun Protection Measures. Spending time in the sunincreases 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 oher sun protection measures including:
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses
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INACTIVE INGREDIENT
Inactive Ingredients:
Water (Aqua), Glycerin, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Butylene Glycol, Microcrystalline Cellulose, Polymethylsilsquioxane, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense Extract, Carnosine, Lactic Acid, Glycolic Acid, Palmitoyl Hexapeptide-52, Palmitoyl Heptapeptide-18, Dipeptide Diaminobutyroyl Benzylamide Diacetate, Urea, Sodium Stearoyl Lactylate, Saccharide Hydrolysate, Alanine, Glycine, Magnesium Aspartate, Creatine, Pinus Pinaster Bark/Bud Extract, Diglycerin, Ascorbic Acid, Lauryl Lactate, Tocopherol, Lactobaillus Ferment, Diethylhexyl Syringylidenemalonate, Saccharomyces Cerevisiae Extract, Ascorbyl Palmitate, Disodium EDTA, Behenyl Alcohol, C20-22 Alcohol, Sodium Hydroxide, Citric Acid, Dimethicone, Caprylic/Capric Triglyceride, PEG-8, Isodecyl Neopentanoate, Polyglyceryl-10 Pentastearate, Diisopropyl Sebacate, Ethylhexylglycerin, C20-22 Alkyl Phosphate, Steareth-21, Cellulose Gum, Polyvinyl Alcohol, Xanthan Gum, Fragrance (Parfum) Linalool, Citronellol, Hydroxycitronellal, Hexyl Cinnamal, Benzyl Benzoate, Butylphenyl Methylpropional, Evernia Furfuracea (Treemoss) Extract, Phenoxyethanol, Potassium Sorbate, Sodium Dehydroacetate, Dehydroacetic Acid, Reg 4 (CI 14700), Yellow 5 (CI 19140)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LINE INTERCEPTION POWER DUO DAY CREAM SUNCREEN BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68807-326 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.7 g in 100 kg HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.0 g in 100 kg OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 kg OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.0 g in 100 kg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCOPROTEIN HORMONES ALPHA CHAIN (UNII: 8YJ68CQ409) ASIAN GINSENG (UNII: CUQ3A77YXI) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) CARNOSINE (UNII: 8HO6PVN24W) LACTIC ACID (UNII: 33X04XA5AT) GLYCOLIC ACID (UNII: 0WT12SX38S) DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE (UNII: 38H206R00R) UREA (UNII: 8W8T17847W) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) INVERT SUGAR (UNII: ED959S6ACY) ALANINE (UNII: OF5P57N2ZX) GLYCINE (UNII: TE7660XO1C) MAGNESIUM ASPARTATE (UNII: R17X820ROL) CREATINE (UNII: MU72812GK0) DIGLYCERIN (UNII: 3YC120743U) ASCORBIC ACID (UNII: PQ6CK8PD0R) LAURYL LACTATE (UNII: G5SU0BFK7O) TOCOPHEROL (UNII: R0ZB2556P8) LACTOBACILLUS REUTERI (UNII: 9913I24QEE) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) ASCORBYL PALMITATE (UNII: QN83US2B0N) EDETATE DISODIUM (UNII: 7FLD91C86K) DOCOSANOL (UNII: 9G1OE216XY) SODIUM HYDROXIDE (UNII: 55X04QC32I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIMETHICONE (UNII: 92RU3N3Y1O) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP) STEARETH-21 (UNII: 53J3F32P58) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) POLYVINYL ALCOHOL (UNII: 532B59J990) XANTHAN GUM (UNII: TTV12P4NEE) LINALOOL, (+/-)- (UNII: D81QY6I88E) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) BENZYL ALCOHOL (UNII: LKG8494WBH) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) GERANIOL (UNII: L837108USY) BENZYL BENZOATE (UNII: N863NB338G) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) PSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) DEHYDROACETIC ACID (UNII: 2KAG279R6R) FD&C RED NO. 4 (UNII: X3W0AM1JLX) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68807-326-11 60 kg in 1 DRUM; Type 0: Not a Combination Product 04/14/2016 2 NDC:68807-326-22 120 kg in 1 DRUM; Type 0: Not a Combination Product 04/14/2016 3 NDC:68807-326-33 78.4 kg in 1 DRUM; Type 0: Not a Combination Product 04/14/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/14/2016 Labeler - Temmentec AG (480586411) Registrant - Temmentec AG (480586411) Establishment Name Address ID/FEI Business Operations Temmentec AG 480586411 manufacture(68807-326)
