Label: AFTER SHAVE BROAD SPECTRUM SPF 15- avobenzone, octocrylene, phenylbenzimidazole sulfonic acid lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 24559-080-01, 24559-080-02 - Packager: Dermstore, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 March 16, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients purpose
Avobenzone 3.0% Sunscreen
Octocrylene 2.75% Sunscreen
Phenylbenzimidazole Sulfonic Acid 4.0% Sunscreen
Uses
• Helps prevent sunburn
• If used as directed with other sun protection
measures (see Directions), decreases the
risk of skin cancer and early skin aging
caused by sun.Keep out of reach of children. If Swallowed, get medical help or contact a Poison Control Center.
Stop use and ask a doctor if rash occurs
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.
Directions
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
children under 6 months: ask a doctor
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer an early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum of at least 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. - 2p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
Water, Ethylhexyl Benzoate, Sodium Phytate, Arginine, Cetearyl Alcohol, Glycerin, Betaine, Cyclopentasiloxane, Caprylyl Methicone, Dimethicone, Behenyl Alcohol, Biosaccharide Gum-1, Glyceryl Stearate, Hydrogenated Lecithin, Lauroyl Lysine, PEG-100 Stearate, Steareth-21, Hordeum Distichon (Barley) Extract, Phellodendron Amurense Bark Extract, Santalum Album (Sandalwood) Extract, Dipotassium Glycyrrhizate, Ergothioneine, Persea Gratissima (Avocado) Oil, Beta Vulgaris (Beet) Root Extract, Butyrospermum Parkii (Shea) Butter, Vitis Vinifera (Grape) Seed Oil, Glycine Soja (Soybean) Seed Extract, Hydrolyzed Beta-Glucan, Vitis Vinifera Seed Extract, Phragmites Kharka Extract, Poria Cocos Extract, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Hydroxyacetophenone, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Unsaponifiables, Squalane, Dimethicone Crosspolymer, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Hydrolyzed Corn Starch, Chlorphenesin, 1,2-Hexanediol, Lecithin, Isohexadecane, Tocopheryl Acetate, Cyamopsis Tetragonoloba (Guar) Gum, Xanthan Gum, Steareth-2, Sodium Acrylates Copolymer, Allantoin, Plukenetia Volubilis Seed Oil, Retinyl Palmitate, Polysorbate 80, Butylene Glycol, Hexylene Glycol, Ethylhexylglycerin, Caprylyl Glycol, Phenoxyethanol, Fragrance.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AFTER SHAVE BROAD SPECTRUM SPF 15
avobenzone, octocrylene, phenylbenzimidazole sulfonic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24559-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.7 g in 100 mL ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13) PHYTATE SODIUM (UNII: 88496G1ERL) ARGININE (UNII: 94ZLA3W45F) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) BETAINE (UNII: 3SCV180C9W) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) DIMETHICONE (UNII: 92RU3N3Y1O) DOCOSANOL (UNII: 9G1OE216XY) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) LAUROYL LYSINE (UNII: 113171Q70B) PEG-100 STEARATE (UNII: YD01N1999R) STEARETH-21 (UNII: 53J3F32P58) BARLEY (UNII: 5PWM7YLI7R) PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) SANDALWOOD (UNII: 3641YW25N2) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) ERGOTHIONEINE (UNII: BDZ3DQM98W) AVOCADO OIL (UNII: 6VNO72PFC1) BETA VULGARIS (UNII: 4G174V5051) VITIS VINIFERA SEED (UNII: C34U15ICXA) SOYBEAN (UNII: L7HT8F1ZOD) FU LING (UNII: XH37TWY5O4) ALOE VERA LEAF (UNII: ZY81Z83H0X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) COCONUT OIL (UNII: Q9L0O73W7L) SQUALANE (UNII: GW89575KF9) CHLORPHENESIN (UNII: I670DAL4SZ) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) ISOHEXADECANE (UNII: 918X1OUF1E) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GUAR GUM (UNII: E89I1637KE) XANTHAN GUM (UNII: TTV12P4NEE) STEARETH-2 (UNII: V56DFE46J5) ALLANTOIN (UNII: 344S277G0Z) PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) POLYSORBATE 80 (UNII: 6OZP39ZG8H) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24559-080-02 1 in 1 CARTON 1 NDC:24559-080-01 100 mL in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/19/2013 Labeler - Dermstore, LLC (015792160) Registrant - wasatch Labs (962452533) Establishment Name Address ID/FEI Business Operations wasatch Labs 962452533 manufacture(24559-080)
