Label: SOLAR DEFENSE BOOSTER SPF50- avobenzone and octinoxate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68479-000-00, 68479-000-02, 68479-000-04 - Packager: Dermalogica, Inc.
- 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 December 16, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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Uses
- helps prevent sunburn.
- if used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- reapply:
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- at least every two hours
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- use a water resistant sunscreen
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- if swimming or sweating
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
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- limit time in the sun, especially from 10 a.m. – 2 p.m.
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- wear long-sleeve shirts, pants, hats and sunglasses
- Children under 6 months: ask a doctor
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Inactive ingredients
Water/Aqua, Butylene Glycol, Carthamus Tinctorius (Safflower) Oleosomes, C12-15 Alkyl Benzoate, Polysorbate 80, Ammonium Acryloyldimethyltaurate/VP Copolymer, Dimethyl Capramide, Nylon-12, Centella Asiatica Extract, Echinacea Purpurea Extract, Magnesium Ascorbyl Phosphate, Melissa Officinalis Leaf Extract, Camellia Oleifera Leaf Extract, Citrus Medica Limonum (Lemon) Peel Extract, Vitis Vinifera (Grape) Seed Extract, Lavandula Angustifolia (Lavender) Oil, Lecithin, Tocopherol, Allantoin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ascorbyl Tetraisopalmitate, Cocamidopropyl PG-Dimonium Chloride Phosphate, Sorbitan Sesquicaprylate, Caprylic/Capric Triglyceride, Squalane, Carbomer, Sodium DNA, Polysorbate 60, Disodium EDTA, Sodium Benzoate, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol, Titanium Dioxide (CI 77891).
- Other information
- Questions or comments
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
SOLAR DEFENSE BOOSTER SPF50
avobenzone and octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) NYLON-12 (UNII: 446U8J075B) CENTELLA ASIATICA (UNII: 7M867G6T1U) ECHINACEA PURPUREA (UNII: QI7G114Y98) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) LEMON PEEL (UNII: 72O054U628) VITIS VINIFERA SEED (UNII: C34U15ICXA) LAVENDER OIL (UNII: ZBP1YXW0H8) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) TOCOPHEROL (UNII: R0ZB2556P8) ALLANTOIN (UNII: 344S277G0Z) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SQUALANE (UNII: GW89575KF9) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) HERRING SPERM DNA (UNII: 51FI676N6F) POLYSORBATE 60 (UNII: CAL22UVI4M) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-000-02 1 in 1 CARTON 1 50 mL in 1 BOTTLE, PLASTIC 2 NDC:68479-000-00 2 mL in 1 POUCH 3 NDC:68479-000-04 125 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/13/2012 Labeler - Dermalogica, Inc. (177698560) Establishment Name Address ID/FEI Business Operations Gordon 008328619 MANUFACTURE(68479-000) Establishment Name Address ID/FEI Business Operations Diamond Wipes 161104729 MANUFACTURE(68479-000)
